Recall Z-1650-2014 ยท DWJ System, Thermal Regulating
Smiths Medical ASD, Inc.
SW-2008 Snuggle Warm Sterile Cardiac Connective Warming Blanket; used with the Equator Convective Warmer, are intended for thermal regulation of a patient's temperture and are designed to prevent hypothermia and/ or reduce cold discomfort during and after surgical procedures.
| Date | May 22, 2014 (initiated Apr 22, 2014) |
| Status | Terminated |
| Reason | The hose could separate from the blanket. |
| Root cause | Process change control |
| Action | 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. |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040632 | SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM, MODEL SW4000 Smiths Medical Asd, Inc., Apr 27, 2004 |