—#159624

Product

Sensicare Green Surgical Glove, PI, LF, PF. Packaged in a poly/poly peel pouch with Sunoco films, sterile. Surgical glove.

FDA product code: KGO — Surgeon'S Gloves
Device class: Class 1
Medical specialty: General, Plastic Surgery
510(k) numbers: K040503
Affected lot / code info: Model No. MSG1285, Lot No. 701893369485

Why it was recalled

Possible open seal on top portion of the package. Could cause breach of sterility.

Root cause (FDA determination)

Packaging

Action the firm took

Medline Industries sent an Immediate Action Required Letter dated October 23, 2017, to all affected customers.. Instructions included to check inventory and quarantine affected product, complete and return the response form to Medline, arrange for the return of any affected product, and notify any customers if the product was further distributed. Customers with questions were instructed to call 866-359-1704.

Recalling firm

Firm: Medline Industries Inc
Address: Three Lakes Drive, Northfield, Illinois 60093

Distribution

Distribution pattern: Worldwide Distribution - US including AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. Internationally to Canada.

Timeline

Recall initiated: 2017-10-23
Posted by FDA: 2017-11-21
Terminated: 2021-04-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #159624. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.