Recall Z-2732-2015 ยท KOD Catheter, Urological
C.R. Bard, Inc.
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
| Date | Sep 3, 2015 (initiated Aug 24, 2015) |
| Status | Terminated |
| Reason | Potential breach of the sterile barrier packaging. |
| Root cause | Unknown/Undetermined by firm |
| Action | The firm, Bard, sent an "URGENT: MEDICAL PRODUCT RECALL" letter dated August 20, 2015 to customers via FedEx on 8/24/2015. The letter describes the product, problem and actions to be taken. The customers were instructed to not use or further distribute any affected product; check inventory and remove any identified affected product from your shelves; complete and return the Recall and Effectiveness Check Form by September 19, 2015, even if you have used or no longer have possession of the affected product, via fax to 1-770-784-6469 or email a scanned copy to Regan.Gealy@crbard.com ( if you can |
| Quantity | 8,970 each |
| Distribution | US Distribution to states of:CA, FL, IL, MA, MN, NH, NJ, NY, NC, OH, OK, PA, TX, and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K000723 | HYDROPHILIC SILICONE FOLEY CATHETER AND PERSONAL CATHETER (HYDROPHILIC AND NON-HYDROPHILIC) Rochester Medical Corp., May 19, 2000 |