The Recall Desk
ModerateFDA (Devices)·Z-2520-2021·Announced 2021-09-29

Decompression Needle Recall Due to Incorrect Instructions for Use

North American Rescue is recalling 51,424 units of 10 ga ARS Decompression Needles due to incorrect Instructions for Use. Affected parties should stop using and contact manufacturer.

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: FDA Class II recall involving incorrect instructions with no reported illnesses or injuries. The hazard is a labeling/documentation error rather than a safety defect with demonstrated harm.

Plain-English summary

North American Rescue LLC is recalling 51,424 units of the 10 ga ARS Decompression Needle, Part Number ZZ-0298, because the device includes incorrect Instructions for Use.

The recalled product was distributed throughout the United States and Puerto Rico, with international distribution to Australia, Czech Republic, Denmark, France, Germany, Ireland, Italy, Poland, and Switzerland. Affected lot numbers are W668NI, W693WF, W694ZH, W695DD, W696FN, and W697IJ.

Healthcare facilities, emergency medical personnel, and others in possession of this device should stop using it and contact North American Rescue for corrected instructions or a replacement unit.

The recalled product

Product
10 ga ARS Decompression Needle, Part Number ZZ-0298
Manufacturer
North American Rescue LLC.
Category
Medical Device — Emergency Medical Device
Hazard
  • mis-labeling
  • incorrect-instructions

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 (8)

  • Part Number
  • ZZ-0298
  • Lots: o W668NI
  • W693WF
  • W694ZH
  • W695DD
  • W696FN
  • W697IJ

Distribution

Distribution scope not specified by the agency.

Related recalls

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