Recall Z-0838-2022 ยท KGO Surgeon'S Gloves
Ansell Healthcare Products LLC
Gammex Non-Latex PI Green PI-KARE Skin-friendly PI Technology polyisoprene surgical gloves 7 1/2
| Date | Feb 19, 2022 |
| Status | Open, Classified |
| Reason | Transport company failed to stop at the border for required FDA inspection. |
| Root cause | Other |
| Action | On 02/19/2022, the Recalling Firm initiated notification via email to its Distribution partners and requested that they reach out to their end user customers. The Recalling Firm informed its customers that between February 2nd to 10th, 2022, it shipped Non-Latex surgical gloves with LOT Number 2107481604 and Manufacturing Date 2021-08-05 to some of its distributor partners. As a part of their warehouse inventory rebalancing procedures within North America, the product was transferred from their Canadian warehouse to one of their USA warehouses. When importing into the US, the freight forwarde |
| Quantity | 74 cases |
| Distribution | U.S.: AZ, CA, NV, TX, UT and WA O.U.S.: None |
| 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 |