Device product
In-View Clear Leggings Bulk Non-Sterile
Z-1302-2021
Product summary
- Event
- Event 87431
- Status
- Terminated
- Classification
- Class II
- Quantity
- 21343 units
- Official record key
device-enforcement:Z-1302-2021
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 8430NA; Lot number's: 2460DR2, 2550DR1, 2660DR1, 2470DR2, 2580DR1, 2690DR1, 2480DR2, 2580DR2, 2720DR1, 2520DR1, 2600DR1, 2730DR1, 2530DR1, 2600DR1, 3290DR1, 2540DR1, 2610DR1 3310DR1, 2540DR2, 2650DR1, 3440DR1
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.