Recall Z-1028-2011 ยท BZQ Monitor, Breathing Frequency
Salter Laboratories, Division of Regulatory Affairs
ThermiSense model 5700-A5 The ThermiSense Model 5700-A5 is a nasal cannula that detects thermal variation during breathing cycles and transmits those variations to a remote Alice-5 Polysomnograph via electrical connectors to monitors an adult patient's breathing rate in a sleep laboratory study
| Date | Feb 3, 2011 (initiated Dec 21, 2010) |
| Status | Terminated |
| Reason | The incorrect length and connector were utilized in lot 110810 of the ThermiSense Alice 5, making the product unusable as it will not interface with the sleep labs equipment. |
| Root cause | Employee error |
| Action | Salter Laboratories, Inc. sent an URGENT PRODUCT RECALL LETTER dated December 20, 2010, to all affected customers. The letter identfied the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory for this product and lot number. Contact Salter to arrange for the return of the product. Complete the attached reply form, confirming receipt of the letter, and fax it back to Salter Labs at 1-800-628-4690. For questions regarding this recall call 661-854-3166. |
| Quantity | 41 units |
| Distribution | Nationwide Distribution including CA, CO, DE, ID, IN, KY, MD, MO, and OH, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080922 | SALTER LABS ORAL/NASAL THERMAL AIRFLOW SENSOR Salter Labs, Division of Regulatory Affairs, Jul 25, 2008 |