FDA Recall Open, Classified

Gammex Non-Latex PI Green PI-KARE Skin-friendly PI Technology polyisoprene surgical gloves 7 1/2

Recall: Z-0838-2022 · Initiated February 19, 2022

Recall

Recall Number
Z-0838-2022
Event Number
89691
Firm
Ansell Healthcare Products LLC
FEI Number
3011209798
Product Code
KGO
Status
Open, Classified
Root Cause
Other
Initiated
February 19, 2022
Address
2301 Robb Dr, Reno, NV, 89523-1901

Description

Gammex Non-Latex PI Green PI-KARE Skin-friendly PI Technology polyisoprene surgical gloves 7 1/2

Reason

Transport company failed to stop at the border for required FDA inspection.

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 forwarder inadvertently bypassed a required FDA inspection. After arriving at the USA warehouse, product was shipped prematurely. Customers/Distributors are asked to: 1. Search their system/inventory to identify if affected products are currently in their possession. A visual guide is provided to assist with identifying the impacted product. 2. If impacted products are found in their system/inventory, they are to return the impacted products back to the Recalling Firm, and replacements were be provided free of charge. For questions or assistance in returning the products, contact Customer Service at 1-855-868-5540 or email [email protected].

Distribution

U.S.: AZ, CA, NV, TX, UT and WA O.U.S.: None

Quantity

74 cases