The Recall Desk
ModerateFDA (Devices)·Z-1898-2012·Announced 2012-07-04

Salter Labs Recalls Adult Divided Cannula Due to Connector Mismatch

Salter Labs is recalling 242 cases of adult divided cannulas because some units labeled with male luer lock connectors actually contained female luer lock connectors.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any injuries, illnesses, or hospitalizations. The hazard is a labeling/packaging mismatch (male vs. female connector) which is a moderate risk of improper use but does not meet the criteria for High severity (which requires high-risk pathogens or risk-of-harm products where injury has not yet been reported in a more critical context, or specific high-risk mislabeling). It fits the Moderate category for minor labeling errors or low-risk contamination issues where no harm is reported.

Plain-English summary

Salter Labs is recalling 242 cases of Adult Divided Cannula end tidal CO2 sampling devices with male luer-lock connectors. The recall was initiated after a complaint was received and verified indicating that some products labeled as part number SO-1296 with male luer lock connectors actually contained products with female luer lock connectors.

The affected products are identified by Salter Part Number SO-1296, Tri-Anium Part Number 301-P3600, and Lot Number 032612. These devices are intended for the delivery of anesthesia and are for single patient use only. The products were distributed nationwide in the United States, including the states of Florida, Indiana, Kansas, Pennsylvania, and Texas.

Healthcare providers and facilities should stop using the affected devices and contact Salter Labs for further instructions. Consumers should not use these products if they have them in their possession.

The recalled product

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.
Manufacturer
SALTER LABS
Affected units
242

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Salter Part Number SO-1296
  • Tri-Anium Part numaber: 301-P3600
  • Lot number: 032612.

Distribution

Distributed nationwide across the United States.

The notice also names 5 states specifically:

Same manufacturer · SALTER LABS

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