MEDLINE INDUSTRIES, LP - Northfield: Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. OPEN HEART CDS-LF, Model Number: CDS840451L; b. OPEN HEART LINE SET UP, Model Number: DYNJ908179, DYNJ908179A; c. OPEN HEART PACK, Model Number: DYNJ43741B, DYNJ66216, DYNJ66216A, DYNJ66216B, DYNJ66216C; d. OPEN HEART PACK A B, Model Number: DYNJ53984G; e. OPEN HEART PACK A & B, Model Number: DYNJ0283397T, DYNJ0283397U, DYNJ53984F, DYNJ53984G; f. OPEN HEART PACK-LF, Model Number: DYNJ0371669N; g. OPEN HEART PACK-RF-LF, Model Number: DYNJ22232W; h. OPEN HEART PART 2, Model Number: DYNJ901075O, DYNJ901075P; i. OPEN HEART PROCEDURE, Model Number: DYNJ901821A; j. OPEN HEART TAVR CONVERSION PK, Model Number: DYNJ63153B; k. OPEN HEART TAVR PACK, Model Number: DYNJ63099F; l. OPEN VASCULAR UE, Model Number: DYNJ907858A; m. OPEN VASCULAR UE PACK, Model Number: DYNJ62451; n. OR ENDOVASCULAR, Model Number: DYNJ906019B, DYNJ906019C; o. OR INTERVENTIONAL PACK, Model Number: DYNJ81295; p. PACER SET UP PACK, Model Number: DYNJ63069A; q. PACK AV FISTULA, Model Number: DYNJ60115B; r. PACK MINOR VASCULAR, Model Number: NG340C; s. PACK VASCULAR BYPASS, Model Number: DYNJ905692D; t. PEDI EP PACK, Model Number: DYNJ54750G; u. PEDIATRIC CARDIO CATH PACK, Model Number: DYNJ35578G; v. PERCUTANEOUS VASCULAR CDS, Model Number: CDS840487I; w. PERIPHERAL CONTINUOUS NERVE BL, Model Number: PAIN1423A; x. PERIPHERAL VASCULAR, Model Number: DYNJ44562F, DYNJ901068D, DYNJ901068F, DYNJ901068I; y. PERIPHERAL VASCULAR GRAFT, Model Number: SYNJ910022A, SYNJ910022B, SYNJ910022C; z. PERIPHERAL VASCULAR PACK, Model Number: DYNJ82566; aa. PERMA CATH PACK, Model Number: DYNJ62007B; bb. PICC VASCULAR ACCESS PACK, Model Number: PICCNC0010; cc. PK OPEN HEART, Model Number: DYNJ45074C, DYNJ61645A; dd. PK, OPEN HEART, Model Number: DYNJ61645A; ee. PK, VASCULAR, Model Number: DYNJ54305; ff. PORT PACK, Model Number: DYNJ68990A; gg. PORT PICC TUNNEL PACK, Model Number: DYNJ65775A; hh. PQ2 VASCULAR PACK, Model Number: DYNJ68492; ii. PROCEDURE PACK, Model Number: DYNJ43922, DYNJ68968A, DYNJ81618; jj. PRX AV FISTULA PACK, Model Number: DYNJ66184; kk. PUH PERCUTANEOUS ECMO, Model Number: DYNJ907554A, DYNJ907554C; ll. PUMP PACK, Model Number: DYNJ64601B; mm. PURPLE PACK, Model Number: DYNJ62197A, DYNJ62197B; nn. PV CAROTID PACK, Model Number: DYNJ63341D; oo. PV PACK, Model Number: DYNJ46549K, DYNJ46549L; pp. RF OPEN HEART PACK (OHLUK)642, Model Number: DYNJ47660K; qq. RFA VEIN PACK-LF, Model Number: DYNJ61894A; rr. RFD-CAROTID, Model Number: DYNJ54287B; ss. RFD-ENDOVASCULAR OR PACK, Model Number: DYNJ54265A; tt. RFD-MAJOR VASCULAR, Model Number: DYNJ54285B; uu. RFD-MINOR VASCULAR, Model Number: DYNJ54286B; vv. RIGHT HEART PACK-LF, Model Number: DYNJ0565558U; ww. RIGHT HEART TRAY, Model Number: DYNJ40379D; xx. ROCKWAY VASCULAR PACK-LF, Model Number: DYNJ55757C; yy. RRMC CAROTID PACK-2, Model Number: DYNJ33544J, DYNJ33544K, DYNJ33544L; zz. SAC OPEN HEART DR. RUDERSDORF, Model Number: DYNJ908074B; aaa. SCA VEIN PACK, Model Number: DYNJ63817; bbb. SILVER CROSS OPEN HEART, Model Number: DYNJ906102D, DYNJ906102F; ccc. SMALL CARDIOVASCULAR PACK, Model Number: DYNJ83521; ddd. SMALL TRAY VASCULAR PACK, Model Number: DYNJ65418; eee. SPECIALS MINOR RADIOLOGY PACK, Model Number: DYNJ82314; fff. ST CHARLES PORT PACK, Model Number: DYNJ49833I; ggg. ST MARY'S STL OPEN HRT SUPPLY, Model Number: DYNJ20031C; hhh. STEWARD OR VASCULAR PACK G, Model Number: DYNJ80918; iii. STEWARD VASCULAR SAS, Model Number: DYNJ908563; jjj. STROKE KIT, Model Number: DYNJ80506; kkk. STROKE PACK, Model Number: DYNJ69009, DYNJ69009A; lll. SUMMIT SKIN AND VEIN PACK, Model Number: DYNJ54014B; mmm. SVMMC CAROTID PACK, Model Number: DYNJ43861F; nnn. SVMMC AV

Recall number

Z-2302-2023

Recalling firm

MEDLINE INDUSTRIES, LP - Northfield

Product

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. OPEN HEART CDS-LF, Model Number: CDS840451L; b. OPEN HEART LINE SET UP, Model Number: DYNJ908179, DYNJ908179A; c. OPEN HEART PACK, Model Number: DYNJ43741B, DYNJ66216, DYNJ66216A, DYNJ66216B, DYNJ66216C; d. OPEN HEART PACK A B, Model Number: DYNJ53984G; e. OPEN HEART PACK A & B, Model Number: DYNJ0283397T, DYNJ0283397U, DYNJ53984F, DYNJ53984G; f. OPEN HEART PACK-LF, Model Number: DYNJ0371669N; g. OPEN HEART PACK-RF-LF, Model Number: DYNJ22232W; h. OPEN HEART PART 2, Model Number: DYNJ901075O, DYNJ901075P; i. OPEN HEART PROCEDURE, Model Number: DYNJ901821A; j. OPEN HEART TAVR CONVERSION PK, Model Number: DYNJ63153B; k. OPEN HEART TAVR PACK, Model Number: DYNJ63099F; l. OPEN VASCULAR UE, Model Number: DYNJ907858A; m. OPEN VASCULAR UE PACK, Model Number: DYNJ62451; n. OR ENDOVASCULAR, Model Number: DYNJ906019B, DYNJ906019C; o. OR INTERVENTIONAL PACK, Model Number: DYNJ81295; p. PACER SET UP PACK, Model Number: DYNJ63069A; q. PACK AV FISTULA, Model Number: DYNJ60115B; r. PACK MINOR VASCULAR, Model Number: NG340C; s. PACK VASCULAR BYPASS, Model Number: DYNJ905692D; t. PEDI EP PACK, Model Number: DYNJ54750G; u. PEDIATRIC CARDIO CATH PACK, Model Number: DYNJ35578G; v. PERCUTANEOUS VASCULAR CDS, Model Number: CDS840487I; w. PERIPHERAL CONTINUOUS NERVE BL, Model Number: PAIN1423A; x. PERIPHERAL VASCULAR, Model Number: DYNJ44562F, DYNJ901068D, DYNJ901068F, DYNJ901068I; y. PERIPHERAL VASCULAR GRAFT, Model Number: SYNJ910022A, SYNJ910022B, SYNJ910022C; z. PERIPHERAL VASCULAR PACK, Model Number: DYNJ82566; aa. PERMA CATH PACK, Model Number: DYNJ62007B; bb. PICC VASCULAR ACCESS PACK, Model Number: PICCNC0010; cc. PK OPEN HEART, Model Number: DYNJ45074C, DYNJ61645A; dd. PK, OPEN HEART, Model Number: DYNJ61645A; ee. PK, VASCULAR, Model Number: DYNJ54305; ff. PORT PACK, Model Number: DYNJ68990A; gg. PORT PICC TUNNEL PACK, Model Number: DYNJ65775A; hh. PQ2 VASCULAR PACK, Model Number: DYNJ68492; ii. PROCEDURE PACK, Model Number: DYNJ43922, DYNJ68968A, DYNJ81618; jj. PRX AV FISTULA PACK, Model Number: DYNJ66184; kk. PUH PERCUTANEOUS ECMO, Model Number: DYNJ907554A, DYNJ907554C; ll. PUMP PACK, Model Number: DYNJ64601B; mm. PURPLE PACK, Model Number: DYNJ62197A, DYNJ62197B; nn. PV CAROTID PACK, Model Number: DYNJ63341D; oo. PV PACK, Model Number: DYNJ46549K, DYNJ46549L; pp. RF OPEN HEART PACK (OHLUK)642, Model Number: DYNJ47660K; qq. RFA VEIN PACK-LF, Model Number: DYNJ61894A; rr. RFD-CAROTID, Model Number: DYNJ54287B; ss. RFD-ENDOVASCULAR OR PACK, Model Number: DYNJ54265A; tt. RFD-MAJOR VASCULAR, Model Number: DYNJ54285B; uu. RFD-MINOR VASCULAR, Model Number: DYNJ54286B; vv. RIGHT HEART PACK-LF, Model Number: DYNJ0565558U; ww. RIGHT HEART TRAY, Model Number: DYNJ40379D; xx. ROCKWAY VASCULAR PACK-LF, Model Number: DYNJ55757C; yy. RRMC CAROTID PACK-2, Model Number: DYNJ33544J, DYNJ33544K, DYNJ33544L; zz. SAC OPEN HEART DR. RUDERSDORF, Model Number: DYNJ908074B; aaa. SCA VEIN PACK, Model Number: DYNJ63817; bbb. SILVER CROSS OPEN HEART, Model Number: DYNJ906102D, DYNJ906102F; ccc. SMALL CARDIOVASCULAR PACK, Model Number: DYNJ83521; ddd. SMALL TRAY VASCULAR PACK, Model Number: DYNJ65418; eee. SPECIALS MINOR RADIOLOGY PACK, Model Number: DYNJ82314; fff. ST CHARLES PORT PACK, Model Number: DYNJ49833I; ggg. ST MARY'S STL OPEN HRT SUPPLY, Model Number: DYNJ20031C; hhh. STEWARD OR VASCULAR PACK G, Model Number: DYNJ80918; iii. STEWARD VASCULAR SAS, Model Number: DYNJ908563; jjj. STROKE KIT, Model Number: DYNJ80506; kkk. STROKE PACK, Model Number: DYNJ69009, DYNJ69009A; lll. SUMMIT SKIN AND VEIN PACK, Model Number: DYNJ54014B; mmm. SVMMC CAROTID PACK, Model Number: DYNJ43861F; nnn. SVMMC AV

Status

Open, Classified

Initiated

2023-05-15

Posted

2023-08-03

Terminated

not on file

Reason

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

Root cause

Nonconforming Material/Component

Action

Medline notified customers beginning on 05/15/2023, via mail and email with letter. Customers with Medline Probe Cover Kits were instructed to check inventory for affected kits, destroy any affected kits, and complete and return the response form. Distributors were instructed to notify their customers and have them document and destroy affected kits. Customers with the non-sterile and sterile procedural kits were instructed to quarantine kits, complete and return the response form and, once updated labels are received, over label and discard the affected ultrasound gel product within the kits. Distributors were instructed to notify customers of the recall and have customers return any affected product for return to Medline. Medline identified additional units of Medline Probe Cover Kits and notified customers on 06/22/2023. Customers were instructed to quarantine kits, complete and return the response form and, once updated labels are received, over label and discard the affected ultrasound gel product within the kits.

Quantity

43,149 kits

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.

Lot, serial or model codes

All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: CDS840451L, UPC Number: 019532715163. b. Model Number: DYNJ908179, UPC Number: 019348999908; Model Number: DYNJ908179A, UPC Number: 019532722257. c. Model Number: DYNJ43741B, UPC Number: 088994282107; Model Number: DYNJ66216, UPC Number: 019348932622; Model Number: DYNJ66216A, UPC Number: 019348991365; Model Number: DYNJ66216B, UPC Number: 019532703430; Model Number: DYNJ66216C, UPC Number: 019532734492. d. Model Number: DYNJ53984G, UPC Number: 019532728288. e. Model Number: DYNJ0283397T, UPC Number: 019348956435; Model Number: DYNJ0283397U, UPC Number: 019532708366; Model Number: DYNJ53984F, UPC Number: 019348946948; Model Number: DYNJ53984G, UPC Number: 019532728288. f. Model Number: DYNJ0371669N, UPC Number: 019348923039. g. Model Number: DYNJ22232W, UPC Number: 019532732560. h. Model Number: DYNJ901075O, UPC Number: 019532705268; Model Number: DYNJ901075P, UPC Number: 019532725355. i. Model Number: DYNJ901821A, UPC Number: 019532731932. j. Model Number: DYNJ63153B, UPC Number: 019348984168. k. Model Number: DYNJ63099F, UPC Number: 019532715003. l. Model Number: DYNJ907858A, UPC Number: 019532713135. m. Model Number: DYNJ62451, UPC Number: 019348965833. n. Model Number: DYNJ906019C, UPC Number: 019348941128. o. Model Number: DYNJ81295, UPC Number: 019532710670. p. Model Number: DYNJ63069A, UPC Number: 019348942361. q. Model Number: DYNJ60115B, UPC Number: 019532711880. r. Model Number: NG340C, UPC Number: 019532730520. s. Model Number: DYNJ905692D, UPC Number: 019532720229. t. Model Number: DYNJ54750G, UPC Number: 019532702135. u. Model Number: DYNJ35578G, UPC Number: 019348980860. v. Model Number: CDS840487I, UPC Number: 019348944534. w. Model Number: PAIN1423A, UPC Number: 019348920182. x. Model Number: DYNJ44562F, UPC Number: 019348973734; Model Number: DYNJ901068D, UPC Number: 019348921186; Model Number: DYNJ901068F, UPC Number: 019348994461; Model Number: DYNJ901068I, UPC Number: 019532723251. y. Model Number: SYNJ910022A, UPC Number: 019348937421; Model Number: SYNJ910022B, UPC Number: 019532700726; Model Number: SYNJ910022C, UPC Number: 019532735820. z. Model Number: DYNJ82566, UPC Number: 019532719802. aa. Model Number: DYNJ62007B, UPC Number: 019532716196. bb. Model Number: PICCNC0010, UPC Number: 019532723117. cc. Model Number: DYNJ45074C, UPC Number: 019348922267; Model Number: DYNJ61645A, UPC Number: 019348978134. dd. Model Number: DYNJ61645A, UPC Number: 019348978134. ee. Model Number: DYNJ54305, UPC Number: 088994247639. ff. Model Number: DYNJ68990A, UPC Number: 019348998136. gg. Model Number: DYNJ65775A, UPC Number: 019532714022. hh. Model Number: DYNJ68492, UPC Number: 019348982724. ii. Model Number: DYNJ43922, UPC Number: 088827707466; Model Number: DYNJ68968A, UPC Number: 019532720684; Model Number: DYNJ81618, UPC Number: 019532712460. jj. Model Number: DYNJ66184, UPC Number: 019348932118. kk. Model Number: DYNJ907554A, UPC Number: 019532702463; Model Number: DYNJ907554C, UPC Number: 019532718383. ll. Model Number: DYNJ64601B, UPC Number: 019532728473. mm. Model Number: DYNJ62197A, UPC Number: 019348999409; Model Number: DYNJ62197B, UPC Number: 019532716724. nn. Model Number: DYNJ63341D, UPC Number: 019532727362. oo. Model Number: DYNJ46549K, UPC Number: 019532700829; Model Number: DYNJ46549L, UPC Number: 019532729066. pp. Model Number: DYNJ47660K, UPC Number: 019348987573. qq. Model Number: DYNJ61894A, UPC Number: 019348973096. rr. Model Number: DYNJ54287B, UPC Number: 019532716711. ss. Model Number: DYNJ54265A, UPC Number: 019532715233. tt. Model Number: DYNJ54285B, UPC Number: 019532714203. uu. Model Number: DYNJ54286B, UPC Number: 019532714578. vv. Model Number: DYNJ0565558U, UPC Number: 019348982703. ww. Model Number: DYNJ40379D, UPC Number: 019348925761. xx. Model Number: DYNJ55757C, UPC Number: 019532711653. yy. Model Number: DYNJ33544J, UPC Number: 019348956435; Model Number: DYNJ33544K, UPC Number: 019348956435; Model Number: DYNJ33544L, UPC Number: 019532727931. zz. Model Number: DYNJ908074B, UPC Number: 019532717268. aaa. Model Number: DYNJ63817, UPC Number: 019348976395. bbb. Model Number: DYNJ906102D, UPC Number: 019348982234; Model Number: DYNJ906102F, UPC Number: 019532702826. ccc. Model Number: DYNJ83521, UPC Number: 019532727464. ddd. Model Number: DYNJ65418, UPC Number: 019348927371. eee. Model Number: DYNJ82314, UPC Number: 019532718421. fff. Model Number: DYNJ49833I, UPC Number: 019348988536. ggg. Model Number: DYNJ20031C, UPC Number: 088438965007. hhh. Model Number: DYNJ80918, UPC Number: 019532708492. iii. Model Number: DYNJ908563, UPC Number: 019532708642. jjj. Model Number: DYNJ80506, UPC Number: 019532704917. kkk. Model Number: DYNJ69009, UPC Number: 019348987684; Model Number: DYNJ69009A, UPC Number: 019532707556. lll. Model Number: DYNJ54014B, UPC Number: 088994276032. mmm. Model Number: DYNJ43861F, UPC Number: 019348998164. nnn. Model Number: DYNJ48153F, UPC Number: 019348998969. ooo. Model Number: DYNJ43777J, UPC Number: 019348999018. ppp. Model Number: DYNJ57539B, UPC Number: 019348930066; Model Number: DYNJ907561, UPC Number: 019348982123; Model Number: DYNJ907561A, UPC Number: 019532702884; Model Number: DYNJ908646, UPC Number: 019532712395; Model Number: DYNJ908646A, UPC Number: 019532731496. qqq. Model Number: DYNJ904401C, UPC Number: 019348934891; Model Number: DYNJ905859, UPC Number: 019348954552. rrr. Model Number: DYNJ52766A, UPC Number: 019348929236; Model Number: DYNJ62915B, UPC Number: 019348936535; Model Number: DYNJ63340A, UPC Number: 019532727358; Model Number: DYNJ66769, UPC Number: 019348938052; Model Number: DYNJ68933, UPC Number: 019348986037; Model Number: DYNJ81095, UPC Number: 019532708412; Model Number: DYNJ82863A, UPC Number: 019532724504. sss. Model Number: DYNJ66152A, UPC Number: 019348982021; Model Number: DYNJ66152B, UPC Number: 019532709042. ttt. Model Number: DYNJ906391D, UPC Number: 019532702147. uuu. Model Number: DYNJ903919J, UPC Number: 019532704590; Model Number: DYNJ903919K, UPC Number: 019532721878; Model Number: DYNJ903919L, UPC Number: 019532726705. vvv. Model Number: DYNJ64449, UPC Number: 019348920157. www. Model Number: TVS4000L, UPC Number: 019532722354. xxx. Model Number: DYNJ55427B, UPC Number: 019348978611; Model Number: DYNJ55427C, UPC Number: 019532712656; Model Number: DYNJ55427D, UPC Number: 019532727261. yyy. Model Number: DYNJ907201, UPC Number: 019348935833; Model Number: DYNJ907201B, UPC Number: 019348994665. zzz. Model Number: DYNJ69622, UPC Number: 019348995958. aaaa. Model Number: DYNJ69302, UPC Number: 019348992627. bbbb. Model Number: DYNJ81705, UPC Number: 019532713557. cccc. Model Number: DYNJ906882A, UPC Number: 019348939123. dddd. Model Number: DYNJ58915, UPC Number: 088994290385; Model Number: DYNJ65842, UPC Number: 019348929631. eeee. Model Number: CDS985355C, UPC Number: 019348931018; Model Number: CDS985355D, UPC Number: 019348944277; Model Number: CDS985355F, UPC Number: 019532724262; Model Number: DYNJ900293J, UPC Number: 019348991514; Model Number: DYNJ902554I, UPC Number: 019348921874; Model Number: DYNJ902704P, UPC Number: 019348986337; Model Number: DYNJ904397D, UPC Number: 019348970120; Model Number: DYNJ904397F, UPC Number: 019348997971; Model Number: DYNJ906021B, UPC Number: 019348941129; Model Number: DYNJ906883A, UPC Number: 019348939820; Model Number: DYNJ909007, UPC Number: 019532724004; Model Number: DYNJ909091, UPC Number: 019532726860. ffff. Model Number: DYNJ59796C, UPC Number: 019348990421. gggg. Model Number: DYNJ81022, UPC Number: 019532708278. hhhh. Model Number: DYNDA2526, UPC Number: 019348919179. iiii. Model Number: DYNJ52606C, UPC Number: 019348973825; Model Number: DYNJ52606D, UPC Number: 019348981280; Model Number: DYNJ52606F, UPC Number: 019348934329. jjjj. Model Number: DYNJ905285C, UPC Number: 019348994725. kkkk. Model Number: DYNJ44420C, UPC Number: 019348959033; Model Number: DYNJ82698, UPC Number: 019532720300. llll. Model Number: DYNJ82109, UPC Number: 019532717124. mmmm. Model Number: DYNJ902259B, UPC Number: 019348991971. nnnn. Model Number: DYNJ904984, UPC Number: 088994278935, Model Number: DYNJ904984B, UPC Number: 019348981293. oooo. Model Number: CDS983040J, UPC Number: 019348924185; Model Number: CDS983040K, UPC Number: 019348984199; Model Number: CDS983136F, UPC Number: 019348921152; Model Number: CDS983136G, UPC Number: 019532714892. pppp. Model Number: CDS982751K, UPC Number: 019348982501. qqqq. Model Number: CDS983390G, UPC Number: 019348982050; Model Number: CDS983390I, UPC Number: 019532710364; Model Number: CDS983390J, UPC Number: 019532720540. rrrr. Model Number: DYNJ902261F, UPC Number: 019348927536; Model Number: DYNJ902261G, UPC Number: 019348991972; Model Number: DYNJ905859, UPC Number: 019348954552. ssss. Model Number: DYNJ37445I, UPC Number: 019348941739. tttt. Model Number: DYNJ81023, UPC Number: 019532708279. uuuu. Model Number: DYNJ53433F, UPC Number: 019348932867. vvvv. Model Number: DYNJ81200, UPC Number: 019532709169; Model Number: DYNJ81200A, UPC Number: 019532722471. wwww. Model Number: DYNJ81642A, UPC Number: 019532726638. xxxx. Model Number: DYNJVB91050A, UPC Number: 019532717172. yyyy. Model Number: DYNJ46100G, UPC Number: 019348926846; Model Number: DYNJ46100I, UPC Number: 019348985640. zzzz. Model Number: DYNJ0103507AF, UPC Number: 019348956435; Model Number: DYNJ0103507AI, UPC Number: 019348956435; Model Number: DYNJ0103507AJ, UPC Number: 019532730242.

510(k) numbers

not on file

PMA numbers

not on file

Product code

OEZ

Firm FEI

1417592

Firm city

Northfield

Firm state

IL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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