Recall Z-0097-2024 ยท KGO Surgeon'S Gloves
Ansell Healthcare Products LLC
NOVAPLUS GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: V20685255 through V20685290
| Date | Oct 11, 2023 (initiated Aug 3, 2023) |
| Status | Open, Classified |
| Reason | Some surgical glove sterile pouches were not completely sealed. |
| Root cause | Process control |
| Action | On 8/3/23, recall notices were mailed or emailed to customers and distributors. Customers who did not respond were contacted via phone. Customers and distributors were asked to do the following: 1) Communicate with all personnel that utilize the product of the risk of and need to discontinue use of the impacted products. 2) Complete the customer Response Form at http://www.novasyte.com/ansell/capa-296-2023 and 3) Return impacted product. If impacted product was purchased from a distributor, contact your distributor directly for further instructions and replacement products. Customers with q |
| Quantity | 378 |
| Distribution | Worldwide - US Nationwide distribution in the states of IN, OH, NY, VA, IL, TN, GA, NY, SC, WI, FL and the country of CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111139 | DERMA PRENE ISOTOUCH GREEN STERILE POWDER-FREE POLYISOPRENE SURGICAL GOVES, TESTED FOR U Ansell Healthcare Products, Inc., Sep 2, 2011 |