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U.S. Department of Health and Human Services

Class 2 Device Recall Adult Divided Cannula end tidal C)2 sampling w/male luerlock connector

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  Class 2 Device Recall Adult Divided Cannula end tidal C)2 sampling w/male luerlock connector see related information
Date Initiated by Firm May 30, 2012
Date Posted June 27, 2012
Recall Status1 Terminated 3 on July 27, 2012
Recall Number Z-1898-2012
Recall Event ID 62272
510(K)Number K892406  
Product Classification Analyzer, gas, carbon-dioxide, gaseous-phase - Product Code CCK
Product Adult Divided Cannula end tidal C)2 sampling w/male luer-lock connector.
7 ft, oxygen tube, 7 ft. CO2 tube
RX only.For Single Patient Use only.
Distributed by Tri-Anium
Assembled in Mexico.

Usage: Delivery of Anesthesia.
Code Information Salter Part Number SO-1296, Tri-Anium Part numaber: 301-P3600; Lot number: 032612.
Recalling Firm/
Manufacturer		 SALTER LABS
100 Sycamore Rd
Arvin CA 93203-2300
For Additional Information Contact Coleen Moyna
661-854-3166
Manufacturer Reason
for Recall		 A complaint was received, and later verified, that product labeled as SO-1296 with male luer lock connector actually contained product with a female luer lock connector.
FDA Determined
Cause 2		 Packaging
Action The firm, Salter Labs, called their customers to discuss the recall and followed up with a "PRODUCT RECALL" letter dated May 29, 2012. The letter was distributed to all customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine their inventory and return any of the lots in their possession to Salter Labs; contact Salter Labs Customer Service at 1-800-235-4203 to arrange for return of the product, and complete and return the attached form/record via fax to: 661-854-6816 or Toll Free 1-800-628-4690. Should you have any questions, please contact Salter Labs at 1-800-235-4203.
Quantity in Commerce 242 cases
Distribution Nationwide distribution: USA including states of: FL, IN, KS, PA and TX.
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 = CCK and Original Applicant = SALTER LABS
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