Recall Z-0573-2015 ยท CAZ Anesthesia Conduction Kit
Arrow International Inc
Arrow Nerve Block Component, Product Code: AB-18040-N: Permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques for periods not exceeding 72 hours.
| Date | Dec 12, 2014 (initiated Nov 10, 2014) |
| Status | Terminated |
| Reason | Arrow is recalling certain lots of the Continuous Nerve Block Component, Product Code: AB-18040-N, due to a labeling inconsistency. The product lidstock incorrectly identifies the needle in the finished good as 17Ga rather than the correct 18Ga. The product included in the package is the correct 18Ga size. No injuries or illnesses have been reported. |
| Root cause | Labeling False and Misleading |
| Action | An urgent medical device recall notification, dated November 11, 2014, was sent to consignees which identified the product, problem, and action to be taken. Customers with affected stock were asked to immediately discontinue use and quarantine any products with the catalog and lot number. To return product, the Recall Acknowledgement Form should be completed and faxed to 1-855-419-8507 Attn: Customer Service or email it to recalls@teleflex.com. A customer service representative will be in contact to provide instructions for the return of product. All customers were asked to complete the Recal |
| Quantity | 786 |
| Distribution | US Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121403 | CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER KIT AND SET Teleflex, Inc., Jun 20, 2012 |