Device product
Sterile Femoral Angiography Drape, Catalog Numbers: a) 29460, b) 29456 - Product Usage: intended to be used as protective patient coverings, such as to isolate the site of a surgical incision from microbial and other contamination.
Z-2037-2021
Product summary
- Event
- Event 88046
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5342 units
- Official record key
device-enforcement:Z-2037-2021
Official wording
Reason: The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is causing the drapes to stick, which may prevent the products from being unfolded and applied properly. Sold in single sterile and bulk non-sterile configurations.
Code information: a) 29460: Lot Numbers: 20LRS055, 20MRS073, 21ARS042 b) 29456: Lot Numbers: 20MMR062
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is causing the drapes to stick, which may prevent the products from being unfolded and applied properly. Sold in single sterile and bulk non-sterile configurations.