Recall StatusTerminated
Date Initiated2009-04-30
Date Terminated2010-01-07
Product Quantity920 cases/10 boxes per case
Reason for Recall
The product may contain defects/holes reducing the product's effectiveness as a barrier.
Firm Action
Consignees were contacted by an Urgent: Medical Recall letter on/about 4/30/2009. The letter instructs the Distributor to extend the recall to the end-user level by notifying each of their customers of the recall via a Customer Recall Letter. Both the Distributor Letter and Customer Letter include Response Sheets that allows for both Distributor and Customer (end-user) to indicate the quantity of affected product they have in their inventory or indicate whether they do not have any affected product. Distributors were instructed to cease further shipment of the product and to physically quarantine the product and fax the completed Response Sheet within 5 business days of receipt of the letter. The customer was instructed to immediately cease further use of the gloves and physically quarantine the product and fax the completed Response Sheet within 5 business days of receipt of the letter. Upon receipt of the Response Sheets, KC will arrange pick-up of the affected products and deliver it to a quarantine location at the contracted warehouse.
Root Cause
Release of Material/Component prior to receiving test results
Distribution Pattern
Nationwide Distribution -- USA including states of CT, MA, MD, NJ, and NY.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.