FDAClass IIJuly 14, 2021

Nonsterile Sterile Cesarean Birth Drape with Dual Layer recall: Sterility Concern

Nonsterile Sterile Cesarean Birth Drape with Dual Layer Anesthesia Screen, Catalog Number 29442N - Product Usage: intended to be used as protective…

Why was Nonsterile Sterile Cesarean Birth Drape with Dual Layer recalled?

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 should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Numbers: 0121QR2, 0391RR1, 3070QR1, 3280QR1, 3280QR2, 3290QR1, 3290QR2, 3300QR1, 3300QR2, 3310QR1, 3310QR2, 3320QR1, 3570QR1, 3570QR2

Product
Nonsterile Sterile Cesarean Birth Drape with Dual Layer Anesthesia Screen, Catalog Number 29442N - Product Usage: intended to be used as protective…
Recalling firm
Cardinal Health 200, LLC
Quantity
6461 units
Distribution
US Nationwide distribution.
Recall date
July 14, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls