Z-1294-2013 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 22, 2013
- Initiation Date
- March 28, 2013
- Termination Date
- June 3, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 19,030 boxes
Product Description
HeliTape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical administration of the Absorbable Collagen Wound Dressings directly over the wound effectively controls bleeding usually within two to five minutes.
Reason for Recall
Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.
Distribution Pattern
Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.
Code Information
1125414, 1126013 1130645, 1110250 1110251, 1110252 1111365, 1111878