ENCORE(R) UNDERGLOVE, Latex, Powder-Free, Smooth Surgical Gloves, REF 2018465, Size 6 1/2, Sterile, Manufactured for Ans
FDA device recall Z-2842-2011 · posted 2011-07-18 · Terminated
Recall details
- Recalling firm
- Ansell Healthcare Products LLC
- 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.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- NPD
- Quantity affected
- 176960 pairs
- Distribution
- Nationwide Distribution
- Date initiated
- 2011-06-10
- Date posted
- 2011-07-18
- Date terminated
- 2013-01-10
- Location
- Dothan, AL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ENCORE STERILE POWDER-FREE LATEX SURGICAL GLOVE WITH PROPRIETARY COATING (CONTAINING GLYCERINE) (K051793) | Ansell Healthcare Products, LLC | 2005-08-17 |