Recalls / —
—#120616
Product
Edwards Lifesciences Suction Wand Model S099B, packaged in Sorin Group Heart/Lung Perfusion Packs.
- FDA product code
- DWF — Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- Device class
- Class 2
- Medical specialty
- Cardiovascular
- 510(k) numbers
- K881330
- Affected lot / code info
- Model S099B
Why it was recalled
Sorin Group is recalling certain lots of Edwards Lifesciences Suction Wand Model S099B due to presence of plastic particles inside the pouch.
Root cause (FDA determination)
Material/Component Contamination
Action the firm took
On 7/8/13, customers and distributors were sent a "Field Safety Notice Product Recall" letter and requested to return unused Edwards Suction Wands found in the Perfusion Packs to the Sorin Group. Customers are to contact Sorin Group Customer Service at 1-800-650-6502 to receive instructions for returning the affected Edwards Suction Wand to Sorin. Customers were also advised to not discard affected product.
Recalling firm
- Firm
- Sorin Group USA, Inc.
- Address
- 14401 W 65th Way, Arvada, Colorado 80004-3503
Distribution
- Distribution pattern
- Nationwide Distribution
Timeline
- Recall initiated
- 2013-07-08
- Posted by FDA
- 2013-08-20
- Terminated
- 2014-01-28
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #120616. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.