FDA Recall
Terminated
Aquasorb Border, Hydrogel Wound Dressing with Polyurethane Film Border, 25 individual packets per case, Catalog # 46-511, 2.5' x 2.5', labeled in part ***Sterile***Manufacturer: DeRoyal 200 Debusk Lane Powell, TN 37849 USA***
Recall: Z-0001-05
·
Initiated July 8, 2004
Recall
- Recall Number
- Z-0001-05
- Event Number
- 29815
- Firm
- DeRoyal Wound Care
- FEI Number
- 1000123222
- Product Code
- MGQ
- Status
- Terminated
- Root Cause
- Other
- Initiated
- July 8, 2004
- Posted
- October 5, 2004
- Terminated
- October 5, 2004
- Address
- Highway 58 PO Box 309, Rose Hill, VA, 24281-0309
Description
Aquasorb Border, Hydrogel Wound Dressing with Polyurethane Film Border, 25 individual packets per case, Catalog # 46-511, 2.5' x 2.5', labeled in part ***Sterile***Manufacturer: DeRoyal 200 Debusk Lane Powell, TN 37849 USA***
Reason
Wound dressing failed to meet sterility specifications.
Action
DeRoyal Wound Care put a hold on remaining lot in inventory pending acceptable dose audit results. The recalling firm notified distributors by phone and letter on 7/8/04 and 7/13/04. The notification advised that the product be segregated to prevent further use and that distributors extend the recall to their consignees if product had been distributed.
Distribution
Product was sold to 3 distributors in CA, OH and PA.
Quantity
4 cases