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.
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: 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.
- Affected units
- 51,424
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
Distributed in 1 state:
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