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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
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