Cardinal Health 200, LLC Recall 87431
Description: In-View Clear Leggings Sterile
Cardinal Health 200, LLC Recall 87431 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1300-2021 |
| Event ID | 87431 |
| Event Description | In-View Clear Leggings Sterile |
| Product Type | Devices |
| 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. |
| Quantity | 28417 units |
| Recall 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. |
| Device Classification | 20210331 |
| Device Code Info | Catalog Number 8430; Lot number's: 20JKS003 (expiration date:2025-09-01), 20JKS004 (expiration date:2025-09-01), 20JKS005 (expiration date:2025-09-01), 20KKS047 (expiration date:2025-10-01), 20KKS050 (expiration date:2025-10-01), 20LKS63 (expiration date:2025-11-01), 20LKS075 (expiration date:2025-11-01), and 20MKS003 (expiration date:2025-12-01). |
| Center Classification Date | 20210324 |
| Recall Initiation Date | 20210225 |
| Recalling Firm | Cardinal Health 200, LLC |
| Initial Notification | Letter |
| Similar To |