Z-1898-2012 Class II Terminated
FDA device recall Z-1898-2012 was initiated by SALTER LABS on May 30, 2012 and is designated Class II. 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. The recall status is terminated (terminated July 27, 2012). Affected quantity: 242 cases.
Recall Details
- Product Type
- Devices
- Report Date
- July 4, 2012
- Initiation Date
- May 30, 2012
- Termination Date
- July 27, 2012
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 242 cases
Product Description
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.
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.
Distribution Pattern
Nationwide distribution: USA including states of: FL, IN, KS, PA and TX.
Code Information
Salter Part Number SO-1296, Tri-Anium Part numaber: 301-P3600; Lot number: 032612.