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
FDA Recall Z-1028-2011 · Posted 2011-02-03
Recalling FirmSalter Laboratories, Division of Regulatory Affairs
Recall StatusTerminated
Product CodeBZQ
Date Initiated2010-12-21
Date Terminated2011-06-06
Product Quantity41 units
Reason for Recall
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.
Firm 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.
Root Cause
Employee error
Distribution Pattern
Nationwide Distribution including CA, CO, DE, ID, IN, KY, MD, MO, and OH,
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.