Device product
Magic3 Intermittent Catheter with Sure Grip Hydrophilic Coated Silicone Coude tip, Product Code 50614. The catheters are packaged in film-to-film pouches and packaged 30 per box. Used as an Intermittent Urinary Catheter
Z-2732-2015
Product summary
- Firm
- C.R. Bard, Inc.
- Event
- Event 72024
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8,970 each
- Official record key
device-enforcement:Z-2732-2015
Official wording
Reason: Potential breach of the sterile barrier packaging.
Code information: Lot Number 53621456
Distribution pattern: US Distribution to states of:CA, FL, IL, MA, MN, NH, NJ, NY, NC, OH, OK, PA, TX, and WA.
Derived failure modes
-
Sterility assurance
breach of the sterile barrier