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Cardinal Health 200, LLC Recall 87431

Description: In-View Clear Leggings Sterile

Cardinal Health 200, LLC Recall 87431 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-1300-2021
Event ID87431
Event DescriptionIn-View Clear Leggings Sterile
Product TypeDevices
DistributionDistributed 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.
Quantity28417 units
Recall ReasonCardinal 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 Classification20210331
Device Code InfoCatalog 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 Date20210324
Recall Initiation Date20210225
Recalling FirmCardinal Health 200, LLC
Initial Notification Letter
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