RecallRadar

FDA Device recall Z-1304-2021

Femoral Angiography Drape Bulk Non-Sterile

On 2021-03-31 the FDA classified a Class II recall of Femoral Angiography Drape Bulk Non-Sterile by Cardinal Health 200, citing 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 t….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1304-2021
ClassificationClass II
Statusterminated
Initiated2021-02-25
Published2021-03-31
Last updated2026-09-13 11:56 UTC
CompanyCardinal Health 200
DistributionUS

Product

Femoral Angiography Drape Bulk Non-Sterile

Reason

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.

Identifiers

code_info
Catalog Number 29560NC; Lot number's: 2450ER1, 2660ER1, 2960ER1, 2450ER2, 2660ER2, 2960ER2, 2460ER1, 2670ER1, 2970ER1,…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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1304-2021%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.