Recall Z-1134-2014 ยท HFX Clamp, Circumcision
DeRoyal Industries Inc
DeRoyal ST. Circumcision Clamp, REF 32-1622, Size 1.3 cm, 1 Per Pack, Rx Only STERILE EO, distributed by DeRoyal Industries.
| Date | Mar 4, 2014 (initiated Jan 16, 2014) |
| Status | Terminated |
| Reason | Three lots of circumcision clamps were manufactured out of specification and as a result may not properly clamp at the surgical site completely. |
| Root cause | Process control |
| Action | DeRoyal initiated the recall by sending overnight letters to its direct accounts on 01/16/2014. If distributors inform DeRoyal of further distribution, DeRoyal will contact those consignees in the same manner. If necessary, further communications will be sent in the form of another mailing, phone calls, and emails to materials management personnel when possible. |
| Quantity | 2504 units |
| Distribution | US Distribution to states of: NJ, AL, TX, WA, IL, OK, VA, FL, OR, and KS. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.