ENCORE (R) Microptic (R) Powder-Free Latex Surgical Gloves, 1 Pair, Size 5, Sterile R, CE 0086, EC REP Ansell (UK) Ltd.,
FDA device recall Z-0621-2011 · posted 2010-12-15 · Terminated
Recall details
- Recalling firm
- Ansell Healthcare Products LLC
- Reason for recall
- open package seams on sterile gloves
- Action taken
- The firm, Ansell, sent a letter dated September 3, 2010 to all customers. The letter described the product, problem and actions taken. An Ansell representatives will contact the customer to remove the gloves bearing the noted lot number from their facility; Ansell will ensure that the gloves removed will be replaced shortly with products from a different manufacturing batch and the recall was extended to the retail (hospital and clinic) level requesting that the product be returned. If you have any questions, contact US (334) 615-2563, international telephone 01.34.24.52.52 and email: infofrance@eu.ansell.com.
- Root cause
- Other
- Status
- Terminated
- Product code
- KGO
- Quantity affected
- 4000 units
- Distribution
- International distribution only: France and Germany
- Date initiated
- 2010-09-03
- Date posted
- 2010-12-15
- Date terminated
- 2011-11-28
- 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 MICROPTIC POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K000295) | Ansell Perry | 2000-02-16 |