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.
FDA Recall Z-0455-2007 · Posted 2007-01-17
Recalling FirmEmbeem Inc.
Recall StatusTerminated
Product CodeNAE
Date Initiated2006-11-09
Date Terminated2008-07-21
Product Quantity1,258 pieces
Reason for Recall
Foreign material- this device, a sterile wound care product, was found to be contaminated with clumps of brown/black foreign material
Firm Action
Recall letters were sent out on 11/9/2006 to the retail level
Root Cause
Other
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.