Recall Z-0309-2012 ยท CAZ Anesthesia Conduction Kit
Arrow International Inc
Arrow International StimuCath(R) Continuous Nerve Block Kit, ASK-19608-SFH, Lot # MF0127039 Permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia of analgesia techniques for periods not exceeding 72 hours
| Date | Nov 30, 2011 (initiated Jun 20, 2011) |
| Status | Terminated |
| Reason | Some of the outer trays used in the packaging of the ASK-19608-SFH Continuous Nerve Block Kits, lot # MF0127039 were found to have an insufficient seal. Therefore, the packaging may have been compromised, and sterility of the product cannot be guaranteed. |
| Root cause | Packaging |
| Action | The firm, Arrow International, sent an "URGENT MEDICAL DEVICE RECALL" letter dated June 20, 2011, to its customer. The letter included a stock response form to be completed and returned to the firm. The letter also described the product, problem and action to be taken. The customer was instructed to check their stock for the products included in the scope of the recall; cease use and distribution; quarantine all affected product immediately; complete and return the enclosed Recall Acknowledgement & Stock Status Form to their sales representative, and return any affected product freight col |
| Quantity | 17 kits |
| Distribution | Nationwide distribution: CT |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021567 | STIMUCATH CONTINUOUS NERVE BLOCK SET, PRODUCT NUMBER AB-05000 Arrow Intl., Inc., Jun 19, 2002 |