Recall Z-0546-2014 ยท CAZ Anesthesia Conduction Kit
Arrow International Inc
Continuous Peripheral Nerve Block Catheter Kit and Set Continuous Peripheral Nerve Block Catheter Kit and Set 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 19, 2013 (initiated Oct 9, 2013) |
| Status | Terminated |
| Reason | A labeling inconsistency was discovered in which the lidstock states that the kit contains a stimulator cable with 1.5mm socket, however, the kit contains a stimulator cable with 1.5mm pin. |
| Root cause | Labeling mix-ups |
| Action | The firm, Arrow International, Inc., sent an "Urgent Medical Device Recall Notification" letter dated October 14, 2013 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately discontinue use and quarantine any of listed affected products/lots you have in stock; return affected products, customer service representative will contact you with RGA# and instructions for the return of the product, and complete enclosed Recall Acknowledgement form and fax to 1-800-343-2935, Attn: Customer Service, even if you have not affected |
| Quantity | 121 |
| Distribution | Worldwide distribution: US (nationwide) including states of: MA, LA, CA, GA, KS, TX, PA, NY, MO, WI, NJ, MS, CT, ID, AL, CO, and PR; and Singapore. |
| 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 |