FDAClass IIJuly 14, 2021

Nonsterile Femoral Angiography Drape with Single Pouch recall: Sterility Concern

Nonsterile Femoral Angiography Drape with Single Pouch, Catalog Number 29525N - Product Usage: intended to be used as protective patient coverings…

Why was Nonsterile Femoral Angiography Drape with Single Pouch 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: 0141ER1, 0141ER2, 2400ER2, 2410ER1, 2410ER2, 2540ER2, 2550ER1, 2550ER2, 2580ER1, 2580ER2, 2590ER1, 2590ER2, 2600ER1, 2760ER2, 2880ER1, 2940ER1, 2940ER2, 3070ER1, 3080ER1, 3530ER1, 3530ER2

Product
Nonsterile Femoral Angiography Drape with Single Pouch, Catalog Number 29525N - Product Usage: intended to be used as protective patient coverings…
Recalling firm
Cardinal Health 200, LLC
Quantity
26250 units
Distribution
US Nationwide distribution.
Recall date
July 14, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls