Device 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
Z-1617-2022
Product summary
- Event
- Event 90336
- Status
- Ongoing
- Classification
- Class II
- Quantity
- a. 25 bx b. 53 bx c. 31 cs
- Official record key
device-enforcement:Z-1617-2022
Official wording
Reason: 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.
Code information: GTIN: a. 00382903649518 EA; 30382903649519 PK; 50382903649513. b. 00382903649532; 30382903649533; 50382903649537. c. 00382903649570 EA; 50382903649575 CS
Distribution pattern: US Nationwide
Derived failure modes
-
Unknown
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.