—#186018

Product

In-View Clear Leggings Sterile Non-Sterile

FDA product code: ILG — Stocking, Elastic
Device class: Class 1
Medical specialty: Physical Medicine
Affected lot / code info: Catalog Number 8430N; Lot number's: 3290DR1 and 3300DR1

Why it was recalled

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.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Cardinal Health 200, LLC
Address: 3651 Birchwood Dr, Waukegan, Illinois 60085-8337

Distribution

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.

Timeline

Recall initiated: 2021-02-25
Terminated: 2024-01-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #186018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.