SW-2008 Snuggle Warm Sterile Cardiac Connective Warming Blanket; used with the Equator Convective Warmer, are intended f
FDA device recall Z-1650-2014 · posted 2014-05-22 · Terminated
Recall details
- Recalling firm
- Smiths Medical ASD, Inc.
- Reason for recall
- The hose could separate from the blanket.
- Action taken
- On April 24, 2014, consignees were notified of the recall via letter. They were instructed to do the following: Inspect inventory and segregate any unused Blankets listed in the notification, complete and return the attached Confirmation Form by fax or e-mail within 7 days of receipt of this notice, and destroy the product.
- Root cause
- Process change control
- Status
- Terminated
- Product code
- DWJ
- Quantity affected
- 2120 devices
- Distribution
- Worldwide Distribution Including the States of CA, IL, KY, MS, NC, TN, TX, WA, WI and the Countries of BH, DE, NO, RU
- Date initiated
- 2014-04-22
- Date posted
- 2014-05-22
- Date terminated
- 2015-02-27
- Location
- Rockland, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM, MODEL SW4000 (K040632) | Smiths Medical Asd, Inc. | 2004-04-27 |