Device recall
Z-0621-2011: ENCORE (R) Microptic (R) Powder-Free Latex Surgical Gloves, 1 Pair, Size 5…
FDA device recall · Class II · Ansell Healthcare Products LLC
Key facts
| Recall number (Z-number) | Z-0621-2011 |
|---|---|
| Recall event | 57269 |
| Product | ENCORE (R) Microptic (R) Powder-Free Latex Surgical Gloves, 1 Pair, Size 5, Sterile R, CE 0086, EC REP Ansell (UK) Ltd., Tamworth, Staffordshire, B79 7UL UK, Ansell Lanka (pvt) Ltd., Biyagama Export Processing Zone, Biyagama, Sri Lanka Intended use: Surgical Gloves |
| Product code | KGO |
| Recalling firm | Ansell Healthcare Products LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 28, 2011 |
| 510(k) numbers | K000295 |
| FEI number | 1019632 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database