Edwards Lifesciences Suction Wand Model S099B, packaged in Sorin Group Heart/Lung Perfusion Packs.
FDA device recall Z-1985-2013 · posted 2013-08-20 · Terminated
Recall details
- Recalling firm
- Sorin Group USA, Inc.
- Reason for recall
- Sorin Group is recalling certain lots of Edwards Lifesciences Suction Wand Model S099B due to presence of plastic particles inside the pouch.
- Action taken
- 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.
- Root cause
- Material/Component Contamination
- Status
- Terminated
- Product code
- DWF
- Quantity affected
- 18,927 packs
- Distribution
- Nationwide Distribution
- Date initiated
- 2013-07-08
- Date posted
- 2013-08-20
- Date terminated
- 2014-01-28
- Location
- Arvada, CO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| COBE HEART/LUNG PERFUSION AND CARDIOPLEGIA PACK (K881330) | Cobe Laboratories, Inc. | 1988-06-10 |