Recall Z-2643-2015 ยท HRX Arthroscope
Customed, Inc
GOWN SURG. POLY REINF. XL XLONG 40/CS CUSTOMED Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
| Date | Sep 3, 2015 (initiated Jul 10, 2015) |
| Status | Terminated |
| Reason | Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. |
| Root cause | Packaging |
| Action | Customed issued an "URGENT VOLUNTARY MEDICAL DEVICE RECALL" notification letter dated July 10, 2015 to all affected customers. The letter identified the product, problem, and actions to be taken by the customer. |
| Quantity | 40 |
| Distribution | Distributed Only in Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K971920 | GOWN POLY REINFORCED LARGE(PRODUCT NO.900-522)/(REORDER NO. 0522) Customed, Inc., Dec 4, 1997 |