Cardinal Health 200, LLC Recall 88046
Description: 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.
Cardinal Health 200, LLC Recall 88046 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2036-2021 |
| Event ID | 88046 |
| Event Description | 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. |
| Product Type | Devices |
| Distribution | US Nationwide distribution. |
| Quantity | 6461 units |
| Recall 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. |
| Device Classification | 20210714 |
| Device Code Info | Lot Numbers: 0121QR2, 0391RR1, 3070QR1, 3280QR1, 3280QR2, 3290QR1, 3290QR2, 3300QR1, 3300QR2, 3310QR1, 3310QR2, 3320QR1, 3570QR1, 3570QR2 |
| Center Classification Date | 20210708 |
| Recall Initiation Date | 20210521 |
| Recalling Firm | Cardinal Health 200, LLC |
| Initial Notification | Letter |
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