Drug recall
RENASYS EZ/ RENASYS EZ Plus 250 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus…
FDA recall event 69146 · Class II · Smith & Nephew, Inc.
Key facts
| Event ID | 69146 |
|---|---|
| Recall numbers | Z-0039-2015, Z-0040-2015, Z-0041-2015 |
| Recalling firm | Smith & Nephew, Inc. |
| Product type | Devices |
| Products | RENASYS EZ/ RENASYS EZ Plus 250 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative…, RENASYS EZ/ RENASYS EZ Plus 800 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative…, RENASYS EZ/ RENASYS EZ Plus 800 mL canister (w/o CLP) with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid. |
| Initiation date | Jul 18, 2014 |
| Report date | Oct 15, 2014 |
| Termination date | Aug 5, 2015 |
| City | Saint Petersburg |
| State | FL |
| Country | United States |
| FEI number | 3006760724 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: