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U.S. Department of Health and Human Services

Enforcement Report - Week of July 5, 2012

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Event Detail

Event ID 62272
Product Type Devices
Status Ongoing
Recalling Firm SALTER LABS
City Arvin
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-05-30
Initial Firm Notification of
Consignee or Public
Telephone
Distribution Pattern Nationwide distribution: USA including states of: FL, IN, KS, PA and TX.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Salter Part Number SO-1296, Tri-Anium Part numaber: 301-P3600; Lot number: 032612. Class II 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. 242 cases Z-1898-2012
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