Recall Z-1300-2021
Cardinal Health 200, LLC · initiated February 25, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
In-View Clear Leggings Sterile
Codes / lots: 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).
Reason for recall
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.
FDA-determined cause: Nonconforming Material/Component
Action taken
A Recall notification letter titled, "URGENT MEDICAL DEVICE RECALL" was sent to consignees on 02/25/2021 via FedEx priority overnight. The consignee is requested to follow the following instructions: 1. CHECK all storage and usage locations to confirm whether they have any units of the affected product codes and lot numbers listed in Attachment 1. 2. SEGREGATE and QUARANTINE all impacted on-hand product. 3) RETURN the enclosed acknowledgment form via facsimile (847-689-9101 or 614-652-9648) or email (GMB-FieldCorrectiveAction@cardinalhealth.com) and indicate the product code, lot and quantity of product they have quarantined. They are requested to please respond regardless of whether or not they have affected product. 4. NOTIFY any customers to whom they may have distributed, or forwarded product affected by this recall. The consignee's notification to their customers may be enhanced by including a copy of this recall notification letter. 5. CONTACT the appropriate Customer Service group to arrange for return and credit/replacement of any affected product. 6. CUSTOMERS that did not receive product directly from Cardinal Health should return product through the location where they purchased it.
Details
- Recall number
- Z-1300-2021
- Initiated
- February 25, 2021
- Terminated
- January 9, 2024
- Product code
- ILG – Stocking, Elastic
- Quantity
- 28417 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.
- Recalling firm
- Cardinal Health 200, LLC, Waukegan, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1301-2021 Class II | In-View Clear Leggings Sterile Non-SterileCardinal Health has determined that a manufacturing variance in a plastic film used to manufacture these… | 02/25/2021Terminated |
| Z-1302-2021 Class II | In-View Clear Leggings Bulk Non-SterileCardinal Health has determined that a manufacturing variance in a plastic film used to manufacture these… | 02/25/2021Terminated |
| Z-1303-2021 Class II | Femoral Angiography Drape SterileCardinal Health has determined that a manufacturing variance in a plastic film used to manufacture these… | 02/25/2021Terminated |
| Z-1304-2021 Class II | Femoral Angiography Drape Bulk Non-SterileCardinal Health has determined that a manufacturing variance in a plastic film used to manufacture these… | 02/25/2021Terminated |