ENCORE(R) UNDERGLOVE, Latex, Powder-Free, Smooth Surgical Gloves, REF 2018460, Size 6, Sterile, Manufactured for Ansell Healthcare, 1635 Industrial Road, Dothan, AL 36303, Made in Sri Lanka Surgical gloves
This recall has been terminated (originally issued July 18, 2011).
- Company
- Ansell Healthcare Products Llc
- Recall Initiated
- June 10, 2011
- Posted
- July 18, 2011
- Terminated
- January 10, 2013
- Recall Number
- Z-2841-2011
- Quantity
- 45692 pairs
- Firm Location
- Dothan, AL
- Official Source
- View on FDA website ↗
Reason for Recall
Gloves do not meet the tensile requirements of ASTM D 3577 reducing the shelf life of the product from 5 years to 2 years.
Distribution
Nationwide Distribution
Lot / Code Info
All codes distributed from February 2008 through May 2011
Root Cause
Other
Action Taken
Ansell Healthcare Products LLC sent an Urgent Voluntary Recall letter dated June 9, 2011, to all affected customers on June 10 and 13, 2011. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to disconstinue use and distribution of any of the affected product and return them to the firm. If the customer distributed gloves further, customers were advised to forward a copy of the notification letter along with their tracking number to their customers. Customers were instructed to complete and return the attached Response Form to Ansell by fax at 1-800-722-8155. Returned product would be replaced or credited to the customer.