Recall Z-0162-2018 ยท KGO Surgeon'S Gloves
Medline Industries Inc
Sensicare Green Surgical Glove, PI, LF, PF. Packaged in a poly/poly peel pouch with Sunoco films, sterile. Surgical glove.
| Date | Nov 21, 2017 (initiated Oct 23, 2017) |
| Status | Terminated |
| Reason | Possible open seal on top portion of the package. Could cause breach of sterility. |
| Root cause | Packaging |
| Action | 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. |
| Quantity | 8,000 units |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040503 | ALOETOUCH POWDER FREE, POLYMER COATED POLYISOPRENE SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA, NATURAL COLOUR Wrp Asia Pacific Sdn. Bhd., Mar 16, 2004 |