MEDLINE INDUSTRIES, LP - Northfield: Medline Convenience kits labeled as: 1) ADMIT KIT , Pack Number DYKA1225B; 2) BRANSON SUPPLEMENTAL PACK , Pack Number DYNDA3019; 3) L & D PACK-LF , Pack Number DYNJ16121O ; 4) FAMILY PLANNING PACK, Pack Number DYNJ59783C ; 5) NEW LIFE PACK , Pack Number DYNJ69208A ; 6) NEW LIFE PACK , Pack Number DYNJ69208B ; 7) RADIOLOGY PACK, Pack Number DYNJ69603; 8)AMBULATORY MINI PACK, Pack Number DYNJ82579; 9) NURSING SKILLS, Pack Number EDUC1023

Recall number

Z-3038-2024

Recalling firm

MEDLINE INDUSTRIES, LP - Northfield

Product

Medline Convenience kits labeled as: 1) ADMIT KIT , Pack Number DYKA1225B; 2) BRANSON SUPPLEMENTAL PACK , Pack Number DYNDA3019; 3) L & D PACK-LF , Pack Number DYNJ16121O ; 4) FAMILY PLANNING PACK, Pack Number DYNJ59783C ; 5) NEW LIFE PACK , Pack Number DYNJ69208A ; 6) NEW LIFE PACK , Pack Number DYNJ69208B ; 7) RADIOLOGY PACK, Pack Number DYNJ69603; 8)AMBULATORY MINI PACK, Pack Number DYNJ82579; 9) NURSING SKILLS, Pack Number EDUC1023

Status

Open, Classified

Initiated

2024-04-08

Posted

2024-09-06

Terminated

not on file

Reason

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Root cause

Under Investigation by firm

Action

Medline Industries LP issued a recall notice to its consignees on 04/08/2024 via letter delivered via USPS and email. The notice explained the issue, provided a link to for information pertaining to the risk involved https://www.fda.gov/medical-devices/safety-communications/update-evaluating-plastic-syringes-made-china-potential-device-failures-fda-safety-communication) and request these syringes within the convenience be discarded, except for circumstances where no alternative syringes are readily available. If these syringes must be used, closely monitor for leaks, breakage, and any other problems, and report any quality issues to Medline and the FDA. Distributors were directed to notify their customers. The firm issued a second recall notice (an expansion) on 05/02/2024 using the same methods.

Quantity

not on file

Distribution

Worldwide distribution.

Lot, serial or model codes

DYKA1225B, Lot Number 21GMC515 ; DYNDA3019, Lot Number 23BBO847 ; DYNDA3019, Lot Number 23GBI102 ; DYNDA3019, Lot Number 23HBO766 ; DYNJ16121O , Lot Number 23BBR366 ; DYNJ16121O , Lot Number 23DBR520 ; DYNJ16121O , Lot Number 23FBU745 ; DYNJ16121O , Lot Number 23GBV975 ; DYNJ16121O , Lot Number 23IBR246 ; DYNJ16121O , Lot Number 23LBR806 ; DYNJ16121O , Lot Number 24ABR196 ; DYNJ59783C , Lot Number 21KMF298 ; DYNJ59783C , Lot Number 23FMC164 ; DYNJ69208A , Lot Number 22KBV360 ; DYNJ69208A , Lot Number 23FBE076 ; DYNJ69208B , Lot Number 23IBN578 ; DYNJ69208B , Lot Number 23KBR836 ; DYNJ69603, Lot Number 21HMG219 ; DYNJ69603, Lot Number 21JMI295 ; DYNJ69603, Lot Number 22BMB206 ; DYNJ69603, Lot Number 22GMB031 ; DYNJ69603, Lot Number 22HMA445 ; DYNJ69603, Lot Number 22HMF745 ; DYNJ69603, Lot Number 22IME788 ; DYNJ69603, Lot Number 22JME874 ; DYNJ69603, Lot Number 23EMD691 ; DYNJ69603, Lot Number 23FMA290 ; DYNJ69603, Lot Number 23FMH511 ; DYNJ82579, Lot Number 23LBO804; DYNJ82579, Lot Number 23KBO218; DYNJ82579, Lot Number 23IBM199; DYNJ82579, Lot Number 23GBQ788; DYNJ82579, Lot Number 23EBT027; DYNJ82579, Lot Number 23EBC375; DYNJ82579, Lot Number 23CBP897; DYNJ82579, Lot Number 23BBG331; DYNJ82579, Lot Number 22LBH343; DYNJ82579, Lot Number 22HBQ045; EDUC1023 , Lot Number 22HDA683 ; EDUC1023 , Lot Number 22HDA854

510(k) numbers

not on file

PMA numbers

not on file

Product code

NSB

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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