Recall Z-2333-2016
C.R. Bard, Inc. · initiated June 29, 2016
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
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
Codes / lots: Lot Number NGZG1722
Reason for recall
Labeling problem
FDA-determined cause: Labeling mix-ups
Action taken
Bard Medical sent an Urgent Medical Device Product Recall letter dated June 29, 2016. The letter identified the product, the problem, and the action to be taken by the customer. The letter requested that customers examine their inventory and quarantine the product. The letter also requested a sub-recall. The letter included a reply form which is to be returned to Bard. Customers were also instructed if product was further distributed they identify customers and notify them at once. Customers with questions should contact the BMD Recall Coordinator at 1-800-793-8110.
Details
- Recall number
- Z-2333-2016
- Initiated
- June 29, 2016
- Terminated
- December 5, 2017
- Product code
- KNX – Collector, Urine, (And Accessories) For Indwelling Catheter
- Quantity
- 530 units
- Distribution
- Nationwide Distribution to CA, FL, IL, IA, KY, NC, MN, NC, OR, RI, SD, TX, UT, and WA.
- Recalling firm
- C.R. Bard, Inc., Covington, GA