smith&nephew EZCARE Negative Pressure Rx only. 100-240 V 12 V 50/60 Hz 90VA T1A 250 V Indicated for patients who would b
FDA device recall Z-0310-2011 · posted 2010-11-03 · Terminated
Recall details
- Recalling firm
- Smith & Nephew Inc.
- Reason for recall
- Smith&Nephew Inc., Advance Wound Management, St Petersburg, FL is recalling their Ezcare Negative Pressure Wound Therapy pumps manufactured by BlueSky Medical Group Inc., between July 17, 2007 and December 13, 2007 and distributed by Smith&Nephew between July 18, 2007 and January 14, 2010. Affected products codes are 66800187, 66800322, 66800323, 66800324, and 66800325 with Serial Numbers startin
- Action taken
- Smith & Nephew Inc. FEDEXed overnight an URGENT DEVICE RECALL letter dated January 27, 2010, to all customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were to check their inventory and identify any affected product, fill out and return the response form by both mail and fax, and return the affected product with the prepaid Federal Express (FedEx) Ground label provided by Smith & Nephew. For any questions regarding this recall contact the Customer Care Center at (800) 876-1261.
- Root cause
- Other
- Status
- Terminated
- Product code
- OMP
- Quantity affected
- 2717 units
- Distribution
- Worldwide Distribution - US including AL, AR, AZ, CA, GA, IL, IN, MA, MD, MD, MO, NC, NJ, NY, OH, OR, PA, TN, TX, and UT and the countries of Australia, UK, South Africa, Canada, Puerto Rico, and New
- Date initiated
- 2010-01-29
- Date posted
- 2010-11-03
- Date terminated
- 2010-11-10
- 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 |
|---|---|---|
| RANASYS EZ NEGATIVE PRESSURE WOUND THERAPY SYSTEM, MODEL 66800059 (K091470) | Smith & Nephew, Inc. | 2009-07-09 |