Device product
OraTape 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.
Z-1296-2013
Product summary
- Event
- Event 64778
- Status
- Terminated
- Classification
- Class II
- Quantity
- 17,110 boxes
- Official record key
device-enforcement:Z-1296-2013
Official wording
Reason: 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.
Code information: 1126012, 1105396 1105397, 1105398 1105399, 1111364 1111641
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.
Derived failure modes
-
Manufacturing or process control
process deviation