Device 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.
Z-1898-2012
Product summary
- Firm
- SALTER LABS
- Event
- Event 62272
- Status
- Terminated
- Classification
- Class II
- Quantity
- 242 cases
- Official record key
device-enforcement:Z-1898-2012
Official wording
Reason: 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.
Code information: Salter Part Number SO-1296, Tri-Anium Part numaber: 301-P3600; Lot number: 032612.
Distribution pattern: Nationwide distribution: USA including states of: FL, IN, KS, PA and TX.
Derived failure modes
-
Unknown
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.