RENASYS EZ/ RENASYS EZ Plus 800 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are
FDA device recall Z-0040-2015 · posted 2014-10-08 · Terminated
Recall details
- Recalling firm
- Smith & Nephew, Inc.
- Reason for recall
- RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid.
- Action taken
- Smith & Nephew sent an Urgent Medical Device Correction Notice dated July 15, 2014 to all US customers via Federal Express delivery. The letter identified the affected product, problem and actions to be taken. The firm instructed customers to discard the affected product and replace with a new one from an unaffected lot. For questions contact 727-399-3785.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- OMP
- Quantity affected
- 77,164 = (75,619 (Item 66800423) & 1,545 (Item 66801066))
- Distribution
- Worldwide Distribution - US Nationwide in the states of FL, NC, CA, MO, MA, TX, NY, OH, CO, VA, IL, NJ, TN, NV, MN including Puerto Rico and countries of Canada, Mexico, Dubai, Argentina, Australia, C
- Date initiated
- 2014-07-18
- Date posted
- 2014-10-08
- Date terminated
- 2015-08-05
- Location
- Saint Petersburg, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO RENASYS EZ PLUS NEGATIVE PRESSURE WOUND THERAPY (K102001) | Smith & Nephew, Inc. | 2010-08-06 |
| RENASYS EZ (K082426) | Smith & Nephew, Inc. | 2008-09-05 |