FDA Enforcement
Class II
Terminated
Sterile Cesarean Birth Drape with Dual Layer Anesthesia Screen, Catalog Number 29442 - 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.
Recall: Z-2035-2021
·
Reported July 14, 2021
Enforcement
- Recall Number
- Z-2035-2021
- Event ID
- 88046
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Cardinal Health 200, LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 14, 2021
- Initiation Date
- May 21, 2021
- Classification Date
- July 8, 2021
- Termination Date
- January 8, 2024
- Address
- 3651 Birchwood Dr, Waukegan, IL, 60085-8337, United States
Description
Sterile Cesarean Birth Drape with Dual Layer Anesthesia Screen, Catalog Number 29442 - 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
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 Info
Lot Numbers: 20LRR092, 20MRR079
Distribution
US Nationwide distribution.
Quantity
1638 units