Recall Z-1012-2011 ยท CAZ Anesthesia Conduction Kit
Arrow International Inc
Arrow WH-02220 - Epidural Catheterization Kit with FlexTip Plus(R) Catheter Intended use: Permits acccess to epidural space, Epidural Anesthesia Kit
| Date | Feb 1, 2011 (initiated Nov 11, 2010) |
| Status | Terminated |
| Reason | Sterility may be compromised. |
| Root cause | Employee error |
| Action | The firm, Arrow International, issued an "URGENT MEDICAL DEVICE RECALL" letter dated November 11, 2010 to their consignees/customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to check their inventory for the affected products, cease use and distribution, quarantine all affected product immediately, return any affected product freight collect along with the completed form via mail to: Arrow International, Inc., 312 Commerce Place, Asheboro, NC 27203, Attn: Asheboro Quality Assurance Manager, and complete and return the FI |
| Quantity | 2320 |
| Distribution | Nationwide Distribution: USA states including IL and LA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K884552 | CONTINUOUS EPIDURAL ANESTHESIA KIT W/POLY CATHETER Arrow Intl., Inc., Mar 14, 1989 |