CLASS II ONGOING Device recall · Reported 3 Aug 2022 · FDA Enforcement Report
Medline Convenience kits labeled as recalled
Medline Industries Lp - SPT is recalling Medline Convenience kits labeled as: a. Major Vascular Cds, b. Post OP Kit, c. Kit Neuro, distributed nationwide in the US. The recall was initiated on 6 Jun 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1474-2022
- FDA event ID
- 90516
- Recalling firm
- Medline Industries Lp - SPT, Waukegan, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 6 Jun 2022
- FDA classified
- 27 Jul 2022
- Reported
- 3 Aug 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Heart & Vascular Devices
Timeline
| 6 Jun 2022 | Recall initiated by company | |
| 27 Jul 2022 | Classified by FDA | +51 days |
| 3 Aug 2022 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Kits contain leaking bottles of isopropyl alcohol
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
Kits contain leaking bottles of isopropyl alcohol
Which lots are affected?
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
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
7 other products · FDA event 90516This product is part of a recall event; the main page for the event is convenience kits labeled as follows recalled.
More recalls from Medline Industries Lp - SPT
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as recalled | Medline Industries Lp - SPT | Packaging Defects | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: LAP Chole recalled | Medline Industries Lp - SPT | Packaging Defects | Nationwide |
| Device | CLASS II | Recalled product recalled by Medline Industries, Lp - Spt | Medline Industries Lp - SPT | Packaging Defects | Nationwide |
| Device | CLASS II | Medline Custom procedural kits labeled as follows recalled | Medline Industries Lp - SPT | Packaging Defects | Nationwide |
| Device | CLASS II | Medline Convenience kits labeled as recalled | Medline Industries Lp - SPT | Packaging Defects | Nationwide |
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