Recall Z-1898-2012— SALTER LABS

Name: FDA recall Z-1898-2012
Creator: U.S. Food and Drug Administration
Published: 2012-05-30

Class II · Terminated

Class II FDA medical device recall by SALTER LABS, initiated 2012-05-30, terminated 2012-07-27. It names one FDA 510(k) clearance: K892406. 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.. 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..

Recalling firm: SALTER LABS
Classification: Class II
Status: Terminated
Initiated: 2012-05-30
Terminated: 2012-07-27
Firm location: Arvin, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K892406 — MODIFIED OXYGEN DELIVERY/CO2 SAMPLE NASAL CANNULASalter Labs·cleared 1989-07-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.