Device product
SureStep Tray, with Add-a-Foley, COMPLETE CARE, Drainage Bag, and STATLOCK Stabilization The product is a urine collection system that includes a STATLOCK Foley Stabilization Device
Z-2333-2016
Product summary
- Firm
- C.R. Bard, Inc.
- Event
- Event 74610
- Status
- Terminated
- Classification
- Class III
- Quantity
- 530 units
- Official record key
device-enforcement:Z-2333-2016
Official wording
Reason: Labeling problem
Code information: Lot Number NGZG1722
Distribution pattern: Nationwide Distribution to CA, FL, IL, IA, KY, NC, MN, NC, OR, RI, SD, TX, UT, and WA.
Derived failure modes
-
Unknown
Labeling problem