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U.S. Department of Health and Human Services

Class 2 Device Recall ThermiSense model 5700A5

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  Class 2 Device Recall ThermiSense model 5700A5 see related information
Date Initiated by Firm December 21, 2010
Date Posted February 03, 2011
Recall Status1 Terminated 3 on June 06, 2011
Recall Number Z-1028-2011
Recall Event ID 57504
510(K)Number K080922  
Product Classification Monitor, breathing frequency - Product Code BZQ
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
Code Information Lot 110810
Recalling Firm/
Manufacturer		 Salter Laboratories, Division of Regulatory Affairs
100 Sycamore Rd
Arvin CA 93203-2300
For Additional Information Contact Gus Bock
661-854-3166
Manufacturer 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.
FDA Determined
Cause 2		 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,
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = BZQ and Original Applicant = SALTER LABS, DIVISION OF REGULATORY AFFAIRS
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