FDAClass IIMarch 31, 2021

Femoral Angiography Drape Bulk Non-Sterile recall

Femoral Angiography Drape Bulk Non-Sterile

Why was Femoral Angiography Drape Bulk Non-Sterile recalled?

Cardinal Health has determined that a manufacturing variance in a plastic film used to manufacture these products is causing the drapes and leggings to stick , which may prevent the products from being unfolded and applied properly.

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?

Catalog Number 29560NC; Lot number's: 2450ER1, 2660ER1, 2960ER1, 2450ER2, 2660ER2, 2960ER2, 2460ER1, 2670ER1, 2970ER1, 2460ER2, 2670ER2, 2970ER2, 2470ER1, 2690ER1, 3030ER1, 2470ER2, 2690ER2, 3030ER2, 2480ER1, 2720ER1, 3040ER1, 2480ER2, 2720ER2, 3040ER2, 2510ER1, 2730ER1, 3080ER2, 2510ER2, 2730ER2, 3090ER1, 2520ER1, 2740ER1, 3090ER2, 2520ER2, 2740ER2, 3100ER1, 2530ER1, 2750ER1, 3100ER2, 2530ER2, 2750ER2, 3150ER1, 2540ER1, 2760ER1, 3160ER1, 2600ER2, 2760ER2, 3170ER1, 2610ER1, 2820ER1, 3180ER1, 2610ER2, 2820ER2, 3210ER1, 2620ER1, 2830ER1, 3290FR1, 2620ER2, 2830ER2, 3490FR1, 2650ER1, 2860ER1, 2650ER2, 2950ER2

Product
Femoral Angiography Drape Bulk Non-Sterile
Recalling firm
Cardinal Health 200, LLC
Quantity
83213 units
Distribution
Distributed nationwide to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV. Distributed also to Australia and Canada.
Recall date
March 31, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls