(1) Medline Sterile Hand Pack, Item DYNJ63380A, 3 kits per case,… — Class II medical device recall Z-1163-2023
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2023-03-01, distributed nationwide. The convenience trays had improper placement of some of the components that were in the nonsterile portion of
| Recall number | Z-1163-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States |
| Recall initiated | 2022-12-27 |
| Classified | 2023-02-23 |
| Reported by FDA | 2023-03-01 |
| Distributed | Nationwide (US) |
| Quantity | 1,689 trays |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 40193489230339, 40193489956895 |
| Lot numbers | 2/28./2023, 20ILA054, 20ILA217, 20ILA518, 20ILA666, 20JLA617, 21BLA250, 21DLA284, 21HLA016, 21ILA354, 21JLA196, 21KLA245, 21LLA141, 22ALA377, 22CLB011, 22ELA046EXP, 22FLA125 |
| Model numbers | DYNJ63380A, DYNJ63380C |
| Expiration dates | 2022-11-30, 2023-02-28, 2023-10-31, 2023-12-31, 2024-01-31 |
Product
(1) Medline Sterile Hand Pack, Item DYNJ63380A, 3 kits per case, contains BD Chloraprep Hi-Lite Orange, 26 mL Applicator, Vendor PN: 930815NS; and (2) Medline Sterile Hand Pack, Item DYNJ63380C, 3 kits per case, contains BD Chloraprep Hi-Lite Orange, 26 mL Applicator, Vendor PN: 930815NS.
Reason for recall
The convenience trays had improper placement of some of the components that were in the nonsterile portion of the tray, thus, not receiving sterilization.
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-1163-2023. 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.