Medline Custom procedural kits labeled as follows: a — Class II medical device recall Z-1476-2022
Ongoing recall by MEDLINE INDUSTRIES, LP - SPT, reported 2022-08-03, distributed nationwide. Kits contain leaking bottles of isopropyl alcohol
| Recall number | Z-1476-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MEDLINE INDUSTRIES, LP - SPT, Waukegan, IL, United States |
| Recall initiated | 2022-06-06 |
| Classified | 2022-07-27 |
| Reported by FDA | 2022-08-03 |
| Distributed | Nationwide (US) |
| Quantity | 2,850 units |
| Reason classes | packaging |
| Lot numbers | 19HBK497, 21CBM834, 21DBE120, 21EBC547, 21EDA767, 21FBB095, 21FBE311, 21FBF231, 21FBF247, 21FBI236, 21FBP377, 21FBR040, 21FBS310, 21GBB010, 21GBG678, 21GBG761, 21GBS468, 21GDA239, 21GDC130, 21GMB680, 21HBF322, 21HBN643, 21HBP246, 21HBP293, 21HDA996, 21IBD953, 21IBL346, 21IBO781, 21JBB951, 21JBM657, 21JBT126, 21JBX562, 21JBX775, 21KBG431, 21KBX711, 21KBX882, 21KDA879, 21KDA985, 21KDB423, 21KDC417 and 37 more |
| Model numbers | A.DYNJ0397191V, DYKMBNDL138, DYKMBNDL40A, DYNJ0101287I, DYNJ0397191V, DYNJ21243M, DYNJ21244N, DYNJ46530J, DYNJ904040D, DYNJ904040F, DYNJ904818C, DYNJ904818D, DYNJ905194, DYNJ905753A, DYNJ907374, DYNJ908260 |
Product
Medline Custom procedural kits labeled as follows: a. GP-NEURO PACK, b. KIT NEUR FUS LUM POST, c. KIT PEDI VP SHUNT, d. KIT STC NEURO SPINE GENERIC, e. MAIN BASIC NEURO, f. MAJOR NEURO PK-LF, g. NEURO, h. NEURO CERVICAL PACK, i. NINOR NEURO PK-LF, j. VP SHUNT PACK Model/Catalog Number: Model Numbers: a.DYNJ0397191V, b. DYKMBNDL138, c. DYNJ907374, d. DYKMBNDL40A, e. DYNJ908260, f. DYNJ21243M, g. DYNJ904818D, DYNJ905194, DYNJ904040D, DYNJ904040F, DYNJ904818C, DYNJ905753A, h. DYNJ0101287I, i. DYNJ21244N, j. DYNJ46530J
Reason for recall
Kits contain leaking bottles of isopropyl alcohol
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1476-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.