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
Recall
- Recall Number
- Z-2732-2015
- Event Number
- 72024
- Firm
- C.R. Bard, Inc.
- FEI Number
- 1018233
- Product Code
- KOD
- Status
- Terminated
- Root Cause
- Unknown/Undetermined by firm
- Initiated
- August 24, 2015
- Posted
- September 3, 2015
- Terminated
- August 1, 2016
- Address
- 8195 Industrial Blvd NE, Covington, GA, 30014-1497
Description
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
Potential breach of the sterile barrier packaging.
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 [email protected] ( if you cannot fax or email the form, call 1-770-784-6471 and report the required information verbally); and if you have further distributed any units of the affected lot, identify your customers and notify them at once of this product recall, and return product to Bard Medical Division, 8195 Industrial Blvd., Covington, GA 30014. BMD will provide replacement product or credit for your return product. If you have any questions, please call Vice President, Quality Assurance at 770-784-6119.
US Distribution to states of:CA, FL, IL, MA, MN, NH, NJ, NY, NC, OH, OK, PA, TX, and WA.
8,970 each