Device product
Femoral Angiography Drape Bulk Non-Sterile
Z-1304-2021
Product summary
- Event
- Event 87431
- Status
- Terminated
- Classification
- Class II
- Quantity
- 83213 units
- Official record key
device-enforcement:Z-1304-2021
Official wording
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.
Code information: 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
Distribution pattern: 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.
Derived failure modes
-
Unknown
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.