FDA Medical Device Recalls (openFDA)
SALTER LABS: 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.
- Recall number
- Z-1898-2012
- Recalling firm
- SALTER LABS
- 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.
- Status
- Terminated
- Initiated
- 2012-05-30
- Posted
- 2012-06-27
- Terminated
- 2012-07-27
- 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.
- Root cause
- 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
- 242 cases
- Distribution
- Nationwide distribution: USA including states of: FL, IN, KS, PA and TX.
- Lot, serial or model codes
- Salter Part Number SO-1296, Tri-Anium Part numaber: 301-P3600; Lot number: 032612.
- 510(k) numbers
- ["K892406"]
- PMA numbers
- not on file
- Product code
- CCK
- Firm FEI
- 1314417
- Firm city
- Arvin
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28