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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

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-2036-2021
Event ID88046
Event DescriptionNonsterile 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 TypeDevices
DistributionUS Nationwide distribution.
Quantity6461 units
Recall ReasonThe 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 Classification20210714
Device Code InfoLot Numbers: 0121QR2, 0391RR1, 3070QR1, 3280QR1, 3280QR2, 3290QR1, 3290QR2, 3300QR1, 3300QR2, 3310QR1, 3310QR2, 3320QR1, 3570QR1, 3570QR2
Center Classification Date20210708
Recall Initiation Date20210521
Recalling FirmCardinal Health 200, LLC
Initial Notification Letter
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