Z-2031-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 14, 2021
- Initiation Date
- May 21, 2021
- Termination Date
- January 8, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 574 units
Product Description
Sterile Femoral Angiography Drape with Single Pouch, Catalog Number 29525 - 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.
Reason for Recall
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.
Distribution Pattern
US Nationwide distribution.
Code Information
Lot Numbers: 20LJS033, 20MJS072