Recall Z-0455-2007 ยท NAE Dressing, Wound, Hydrogel Without Drug And/Or Biologic
Embeem Inc.
HiZel, Trayless-sterile hydrogel wound dressing. Sizes 2.4 x 2.4'', 2.4 x 4.7'', & 4.7 x 4.7''. Product is a transparent, flexible sheet. Packaged in a peelable pouch.
| Date | Jan 17, 2007 (initiated Nov 9, 2006) |
| Status | Terminated |
| Reason | Foreign material- this device, a sterile wound care product, was found to be contaminated with clumps of brown/black foreign material |
| Root cause | Other |
| Action | Recall letters were sent out on 11/9/2006 to the retail level |
| Quantity | 1,258 pieces |
| Distribution | There are 47 customers which includes two large distributors/accounts and the rest are internet individual purchasers. These internet purchases amounts are 6 to 18 pieces at a time. There are no government accounts and no international accounts generating from EMBEEM. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.