ThermiSense model 5700-A5 The ThermiSense Model 5700-A5 is a nasal cannula that detects thermal variation during breathi
FDA device recall Z-1028-2011 · posted 2011-02-03 · Terminated
Recall details
- Recalling firm
- Salter Laboratories, Division of Regulatory Affairs
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- BZQ
- Quantity affected
- 41 units
- Distribution
- Nationwide Distribution including CA, CO, DE, ID, IN, KY, MD, MO, and OH,
- Date initiated
- 2010-12-21
- Date posted
- 2011-02-03
- Date terminated
- 2011-06-06
- Location
- Arvin, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SALTER LABS ORAL/NASAL THERMAL AIRFLOW SENSOR (K080922) | Salter Labs, Division of Regulatory Affairs | 2008-07-25 |