Class 2 Device Recall HiZel, trayless, wound dressing, sterile

• Date Initiated by Firm: November 09, 2006
• Date Posted: January 17, 2007
• Recall Status: Terminated on July 21, 2008
• Recall Number: Z-0455-2007
• Recall Event ID: 36831
• Product Classification: Wound Dress - Product Code NAE
• Product: 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.
• Code Information: There are no lot codes. The firm is recalling all trayless product from its shipment dated 3/28/2006.
• FEI Number: 3005089721
• Recalling Firm/ Manufacturer: Embeem Inc.; 18 Ireland Brook Dr; N Brunswick NJ 08902-4761
• For Additional Information Contact: Mitul Majmudar; 732-230-2452
• Manufacturer Reason for Recall: Foreign material- this device, a sterile wound care product, was found to be contaminated with clumps of brown/black foreign material
• FDA Determined Cause: Other
• Action: Recall letters were sent out on 11/9/2006 to the retail level
• Quantity in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.