Z-1474-2022Class II

Medline Convenience kits labeled as: a. MAJOR VASCULAR CDS, b. POST OP KIT, c. KIT NEURO FUS LUM POST SANSUR...

Name: Z-1474-2022 Medline Convenience kits labeled as: a. MAJOR VASCULAR CDS, b. POST OP KIT, c. KIT NEURO FUS LUM POST SANSUR...
Creator: Medline Industries, Lp - Spt
Published: 2022-06-06
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2022-06-06 / Open, Classified

FDA source

MEDLINE INDUSTRIES, LP - SPT began a recall of 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... on 2022-06-06. FDA classified it as Class II and gives the reason as "Kits contain leaking bottles of isopropyl alcohol". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1474-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-06-06
Posted: 2022-07-27
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
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
Product code: LRO General Surgery Tray
Reason for recall: Kits contain leaking bottles of isopropyl alcohol
FDA 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 in commerce: 6569 units
Distribution: US Nationwide distribution.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1474-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1470-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-03	2022-07-27
Z-1471-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-03	2022-07-27
Z-1472-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-03	2022-07-27
Z-1473-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-03	2022-07-27
Z-1474-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-03	2022-07-27
Z-1475-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-03	2022-07-27
Z-1476-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-03	2022-07-27
Z-1477-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-03	2022-07-27

Product code LRO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)