FDA Medical Device Recalls (openFDA)
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
- Recall number
- Z-1028-2011
- Recalling firm
- Salter Laboratories, Division of Regulatory Affairs
- 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
- Status
- Terminated
- Initiated
- 2010-12-21
- Posted
- 2011-02-03
- Terminated
- 2011-06-06
- 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,
- Lot, serial or model codes
- Lot 110810
- 510(k) numbers
- ["K080922"]
- PMA numbers
- not on file
- Product code
- BZQ
- Firm FEI
- 1314417
- Firm city
- Arvin
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28