FDAFDA · Food and drugs·Recall number Z-2036-2021
Nonsterile Sterile Cesarean Birth Drape with Dual Layer Anesthesia Screen, Catalog Number 29442N - 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.
Published July 14, 2021 · Recall initiated: May 21, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Cardinal Health 200, LLC
- Distributor
- US Nationwide distribution.
- Lot
- Lot Numbers: 0121QR2, 0391RR1, 3070QR1, 3280QR1, 3280QR2, 3290QR1, 3290QR2, 3300QR1, 3300QR2, 3310QR1, 3310QR2, 3320QR1, 3570QR1, 3570QR2
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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