ThermoSuit Manufactured for Life Recovery Systems. HD, LLC, 170 Kinnelon Rd. Kinnelon, NJ 07405 USA Tel.: (973) 283-2800
FDA device recall Z-0456-2012 · posted 2012-01-11 · Terminated
Recall details
- Recalling firm
- Life Recovery Systems HD, LLC
- Reason for recall
- ThermoSuit System Model TSP-50 Pump/Controller may have corrosion on the temperature circuit board which may result in incorrect patient temperature reading.
- Action taken
- Life Recovery Systems sent recall letters/return response forms dated 10/24/2011 to all consignees. Life Recovery Systems has expanded their recall to include additional units and to provide additional service to products out in the field. A new recall letter was sent to consignees on 4/27/2012.
- Root cause
- Process control
- Status
- Terminated
- Product code
- NZE
- Quantity affected
- 28 units
- Distribution
- Nationwide Distribution including NY, NC, LA, NJ, AL. PA TX, KY, MO, MA, and TN
- Date initiated
- 2011-10-21
- Date posted
- 2012-01-11
- Date terminated
- 2013-01-24
- Location
- Waldwick, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| THERMOSUIT SYSTEM (K061023) | Life Recovery Systems Hd, LLC | 2006-09-20 |