a — Class II medical device recall Z-1617-2022
Ongoing recall by Mckesson Medical-Surgical Inc. Corporate Office, reported 2022-08-31, distributed nationwide. Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperature
| Recall number | Z-1617-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mckesson Medical-Surgical Inc. Corporate Office, Richmond, VA, United States |
| Recall initiated | 2022-05-25 |
| Classified | 2022-08-25 |
| Reported by FDA | 2022-08-31 |
| Distributed | Nationwide (US) |
| Reason classes | temperature control |
| UPC / GTIN / UDI-DI | 00382903649518, 00382903649532, 00382903649570, 30382903649519, 30382903649533, 50382903649513, 50382903649537, 50382903649575 |
| Model numbers | 364951, 364953, 364957 |
Product
a. BECTON DICKINSON BD Vacutainer C&S Preservative Urine Tube TUBE, URINE COLL PLAS 4ML (100/BX 10BX/CS), Model Number: BD 364951. b. BECTON DICKINSON BD Vacutainer C&S Transfer Straw Kit TRANSFER STRAW KIT, URINE 4ML(50/BX 4BX/CS) Model Number: BD 364953. c. BECTON DICKINSON BD Vacutainer COLLECTION KIT, URINE COMPLETE 8ML 13"X75" (50/CS) BD Model Number: 364957
Reason for recall
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
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-1617-2022. 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.