Z-1028-2011

ThermiSense model 5700-A5 The ThermiSense Model 5700-A5 is a nasal cannula that detects thermal variation...

Name: Z-1028-2011 ThermiSense model 5700-A5 The ThermiSense Model 5700-A5 is a nasal cannula that detects thermal variation...
Creator: Salter Laboratories, Division of Regulatory Affairs
Published: 2010-12-21
License: https://open.fda.gov/license/

Salter Labs / initiated 2010-12-21 / Terminated / root cause: manufacturing process

FDA source

Salter Laboratories, Division of Regulatory Affairs began a recall of ThermiSense model 5700-A5 The ThermiSense Model 5700-A5 is a nasal cannula that detects thermal variation during breathing cycles and transmits those... on 2010-12-21. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1028-2011
Status: Terminated
Initiated: 2010-12-21
Posted: 2011-02-03
Terminated: 2011-06-06
Recalling firm: Salter Labs
Product: 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
Product code: BZQ Monitor, Breathing Frequency
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 41 units
Distribution: Nationwide Distribution including CA, CO, DE, ID, IN, KY, MD, MO, and OH,
Product codes and lots: Lot 110810

Product code BZQ

K080922Class IISalter Labs Oral/nasal Thermal Airflow SensorSalter Labs, Division of Regulatory Affairs / cleared 2008-07-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)