Medline brand medical procedure convenience kits — Class II medical device recall Z-0157-2025
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2024-10-30, distributed nationwide. It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may re
| Recall number | Z-0157-2025 |
|---|---|
| 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 | 2024-09-04 |
| Classified | 2024-10-23 |
| Reported by FDA | 2024-10-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, PA |
| Quantity | 5,238 units |
| Reason classes | sterility, packaging |
| UPC / GTIN / UDI-DI | 10080196200160, 10080196227020, 10193489283938, 10193489498905, 10193489975246, 10195327007744, 10195327055790, 10195327421281, 10195327492861, 10195327562038, 10195327582722, 10884389433089, 10889942253708, 10889942553884, 10889942754144, 40080196200161, 40080196227021, 40193489283939, 40193489293723, 40193489498906, 40193489975247, 40195327007745, 40195327055791, 40195327317233, 40195327421282 and 7 more |
| Lot numbers | 23JBS113, 23KBE939, 23KBK131, 23LBM072, 23LBN003, 23LBN027, 23LBN154, 23LBN198, 23LBN351, 23LBP033, 23LBP745, 23LBT018, 24ABC063, 24ABC903, 24ABD995, 24ABE345, 24ABE939, 24ABG864, 24ABH428, 24ABI626, 24ABK903 |
| Model numbers | CVI4730A, DYNJ20803D, DYNJ28368, DYNJ28487, DYNJ28487H, DYNJ30087C, DYNJ35352, DYNJ52255, DYNJ59067A, DYNJ61247A, DYNJ64542A, DYNJ65519, DYNJ68112, DYNJ69088A, DYNJ80031, DYNJ80489A, DYNJ80643, DYNJ83938 |
Product
Medline brand medical procedure convenience kits, labeled as: a) KIT LINE INSERTION, REF CVI4730A; b) KIT LINE INSERTION, REF CVI4730A; c) LINE INSERTION TRAY, REF DYNJ20803D; d) CENTRAL LINE PACK-LF, REF DYNJ28368; e) CENTRAL LINE PACK-LF, REF DYNJ28368; f) PICC PACK-LF, REF DYNJ28487; g) PICC PACK-LF, REF DYNJ28487H; h) CENTRAL LINE PACK, REF DYNJ30087C; i) CENTRAL LINE ADULT PACK, REF DYNJ35352; j) PICC PACK, REF DYNJ52255; k) PICC PROCEDURE PACK, REF DYNJ59067A; l) PICC PROCEDURE PACK, REF DYNJ59067A; m) DR SIRAGUSA VEIN PACK, REF DYNJ61247A; n) PICC TEAM PACK, REF DYNJ64542A; o) PICC LINE INSERTION PACK, REF DYNJ65519; p) CVL INSERTION KIT II PGYBK, REF DYNJ68112; q) CVL INSERTION KIT II PGYBK, REF DYNJ68112; r) PICC PACK, REF DYNJ69088A; s) PICC INSERTION TRAY, REF DYNJ80031; t) ENDOVENOUS ABLATION PACK, REF DYNJ80489A; u) CVR ENDOVENOUS PACK, REF DYNJ80643; v) RADIAL ARTERY PACK, REF DYNJ83938;
Reason for recall
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
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-0157-2025. 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.