FDA Medical Device Recalls (openFDA)
MEDLINE INDUSTRIES, LP - SPT: Medline Convenience kits labeled as: a. MAJOR VASCULAR CDS, b. POST OP KIT, c. KIT NEURO FUS LUM POST SANSUR, d. KIT NEURO FUS LUM POST SANSUR , e. PRE-OP ACCESSORY KIT CHOICE, f. DEEP BRAIN STIMULATION PACK, g. DEEP BRAIN STIMULATION PACK, h. MINIMALLY INVASIVE PACK-LF, i. EVLP Pack/Kit, j. GENERAL PURPOSE CV, k. GENERAL PURPOSE CV, l. KIT GERMANTOWN CABG, m. KIT GERMANTOWN CABG, n. DENTAL RESTORATIONS, o. ALCOHOL PREP PACK, p. ALCOHOL PREP PACK, q. MATRIXECTOMY PACK-LF Model/Catalog Number: a. CDS981543D, b. DYKM1875, c. DYKMBNDL142A, d. DYKMBNDL142A, e. DYKS1185A, f. DYNJ0842793F, g. DYNJ0842793F, h. DYNJ0843063J, i. DYNJ901205C, j. DYNJ904395F, k. DYNJ904395F, l. DYNJ905855, m. DYNJ905855, n. DYNJ906653A, o. P922260, p. P922260, q. PHS110395003
- Recall number
- Z-1474-2022
- Recalling firm
- MEDLINE INDUSTRIES, LP - SPT
- Product
- Medline Convenience kits labeled as: a. MAJOR VASCULAR CDS, b. POST OP KIT, c. KIT NEURO FUS LUM POST SANSUR, d. KIT NEURO FUS LUM POST SANSUR , e. PRE-OP ACCESSORY KIT CHOICE, f. DEEP BRAIN STIMULATION PACK, g. DEEP BRAIN STIMULATION PACK, h. MINIMALLY INVASIVE PACK-LF, i. EVLP Pack/Kit, j. GENERAL PURPOSE CV, k. GENERAL PURPOSE CV, l. KIT GERMANTOWN CABG, m. KIT GERMANTOWN CABG, n. DENTAL RESTORATIONS, o. ALCOHOL PREP PACK, p. ALCOHOL PREP PACK, q. MATRIXECTOMY PACK-LF Model/Catalog Number: a. CDS981543D, b. DYKM1875, c. DYKMBNDL142A, d. DYKMBNDL142A, e. DYKS1185A, f. DYNJ0842793F, g. DYNJ0842793F, h. DYNJ0843063J, i. DYNJ901205C, j. DYNJ904395F, k. DYNJ904395F, l. DYNJ905855, m. DYNJ905855, n. DYNJ906653A, o. P922260, p. P922260, q. PHS110395003
- Status
- Open, Classified
- Initiated
- 2022-06-06
- Posted
- not on file
- Terminated
- not on file
- Reason
- Kits contain leaking bottles of isopropyl alcohol
- Root cause
- Under Investigation by firm
- Action
- The firm's consignees were notified by US mail on 06/06/2022 and instructed to destroy any affected kits on hand in accordance with their local and state regulations.
- Quantity
- 6569 units
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- Lot Code: a. Model Number CDS981543D, Lot Numbers: 19HBK745; b. Model Number DYKM1875, Lot Numbers: 22ABK810, 22ABO583, 21LBB378; c. Model Number DYKMBNDL142A, Lot Numbers: 22OBJ742, 22ABY101, 21FBQ232, 21HBG594, 21JBA902, 21VBC259, 21DBE917; d. Model Number DYKS1185A, Lot Numbers: 21LBX041, 22CBO060, 21HBI534, 21HBQ840, 21CBT064, 21CBZ524; e. Model Number DYNJ0842793F, Lot Numbers: 22BDB295, 22DDA792, 21EDA769, 21GDB289, 21HDC822; f. Model Number DYNJ0843063J, Lot Numbers: 22CDB166, 22ADC136, 21LDA151, 21EDC220, 21GDC682, 21IDA570, 21JDA064; g. Model Number DYNJ901205C, Lot Numbers: 19HBE998; h. Model Number DYNJ904395F, Lot Numbers: 22DBG340, 22DBH356, 22DBI433, 21GBM221, 21LBO497, 21LBO625, 21DBJ932; i. Model Number DYNJ905855, Lot Numbers: 22DBK812, 22NBE430, 21GBC672, 21GBI192, 21IBT387, 21VBB580, 21DBV520, 21FBG162; j. Model Number DYNJ906653A, Lot Numbers: 22CDB173, 21CDC622; k. Model Number P922260, Lot Numbers: 22DMB774, 22BBK027, 21GBQ268, 21KBS110, 21CBZ538, 21EBI098; l. Model Number PHS110395003, Lot Numbers: 21HBB233, 21CBZ815
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LRO
- Firm FEI
- 3000717925
- Firm city
- Waukegan
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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