The Recall Desk
ModerateFDA (Devices)·Z-0360-2014·Announced 2013-11-27

Salter Labs Recalls CO2 Sample Lines Due to Incorrect Length

Salter Labs is recalling specific lots of 15-foot CO2 sample lines because they may contain 30-foot tubes instead.

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: This is a Class II recall involving a specification error (incorrect tube length) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Salter Labs is recalling three lots of model number 4515-15-25 CO2 Sample Line 15' tubes with male Luer lock connectors. The recall was initiated because it has been determined that these specific lots may contain a 30-foot tube instead of the intended 15-foot length.

The affected product is prescription-only and was distributed in the states of Mississippi, Texas, Florida, Wisconsin, Michigan, Virginia, New York, Missouri, and North Carolina. The recall covers 91 cases, with 25 units per case. The specific lot numbers involved are 071513, 071513A, and 120312.

Healthcare providers and facilities should check their inventory for these specific model and lot numbers. If the product is found, it should be removed from use and returned to Salter Labs according to their instructions.

The recalled product

Product
Salter Labs EtCO2 Sample line 15' (4.6 M) tube, male luer connectors. Rx only; Made in Mexico; Manufacturer:Salter Labs, 100 West Sycamore Road, Arvin, CA 93203. CO2 sample line.
Manufacturer
SALTER LABS

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)

  • Model number: 4515-15-25
  • lot numbers 071513
  • 071513A and 120312.

Distribution

Distributed in 9 states:

Same manufacturer · SALTER LABS

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