The Recall Desk
SevereFDA (Devices)·Z-0812-2014·Announced 2014-01-29

Vital Signs Anesthesia Circuits Recalled Due to Occlusion Risk

Vital Signs Colorado Inc. is recalling anesthesia and ventilator circuits where a blue port cap may be attached, causing gas flow occlusion.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a defect that causes occlusion of gas flow in life-support medical devices, posing a significant risk of serious injury.

Plain-English summary

Vital Signs Colorado Inc. is recalling Vital Signs Anesthesia Circuits, which include ventilator, anesthesia, and CPAP circuits. These devices are intended to serve as interfaces between patients and ventilators, administer medical gases during anesthesia, or increase airway pressure.

The recall is due to an internal inspection error that may result in a blue port cap being inadvertently attached to the circuit. If a circuit in use is occluded by this cap, it will cause an occlusion of gas flow.

The recall covers 1,827,920 units distributed in the United States (including Puerto Rico) and 504,760 units distributed internationally to numerous countries. Affected products include various part numbers listed in the recall documentation. Users should check their devices for the presence of the blue port cap and contact the manufacturer for instructions.

The recalled product

Product
Vital Signs Anesthesia Circuits The Ventilator Circuit is intended for use as an interface between a ventilator dependent patient and a ventilator. The Anesthesia Circuit is intended to administer medical gases to a patient during anesthesia. The CPAP Circuit is intended to in

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 (20)

  • PartNumber : 4S78XX00
  • 155512
  • 155518
  • 156505
  • 156545
  • 1576162
  • 1576214
  • 542011
  • 542021
  • 542031
  • 1553196
  • 1572347
  • 1553402
  • 156205
  • 156310
  • 1574701
  • 1574710
  • 1574711
  • 1574712
  • 1574723

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same manufacturer · Vital Signs Colorado Inc.

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