Z-1898-2012Class II

Adult Divided Cannula end tidal C)2 sampling w/male luer-lock connector. 7 ft, oxygen tube, 7 ft. CO2 tube RX...

Name: Z-1898-2012 Adult Divided Cannula end tidal C)2 sampling w/male luer-lock connector. 7 ft, oxygen tube, 7 ft. CO2 tube RX...
Creator: Salter Labs
Published: 2012-05-30
License: https://open.fda.gov/license/

Salter Labs / initiated 2012-05-30 / Terminated / root cause: packaging

FDA source

SALTER LABS began a recall of 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... on 2012-05-30. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1898-2012
Classification: Class II
Status: Terminated
Initiated: 2012-05-30
Posted: 2012-06-27
Terminated: 2012-07-27
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.
Product code: CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
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.
Root cause tag: packaging
FDA 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 in commerce: 242 cases
Distribution: Nationwide distribution: USA including states of: FL, IN, KS, PA and TX.
Product codes and lots: Salter Part Number SO-1296, Tri-Anium Part numaber: 301-P3600; Lot number: 032612.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1898-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1898-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-04	2012-06-27

Product code CCK

K892406Class IIModified Oxygen Delivery/co2 Sample Nasal CannulaSalter Labs / cleared 1989-07-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)