Recall Z-0714-2007 ยท FRO Dressing, Wound, Drug
Integra Biotechnical LLC
ProWick Shoulder Postoperative Dressing and Cold Therapy System, Model number AR-1625
| Date | Apr 4, 2007 (initiated Feb 1, 2007) |
| Status | Terminated |
| Reason | During routine new product testing, it was discovered that the product may not be sterile, although sterilized in accordance with validated parameters. |
| Root cause | Other |
| Action | An email and/or fax recall notification was sent starting on 02/1/2007 by Arthrex, Inc. (the Primary Distributor) . A product recall notice in the form of a letter was mailed via US Postal Certified Mail, return receipt requested by Arthrex, Inc. to all of the Distributor''s customers starting on 02/1/2007, including those who have not ordered or received the Recalled Product. Customers were asked to 'segregate and protect the product from shipment, and return all unused products to Arthrex, Inc.' |
| Quantity | 1769 |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.