FDAClass IISeptember 29, 2021

10 ga ARS Decompression Needle recall

10 ga ARS Decompression Needle, Part Number ZZ-0298

Why was 10 ga ARS Decompression Needle recalled?

The device includes the incorrect Instructions for Use.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
10 ga ARS Decompression Needle, Part Number ZZ-0298
Recalling firm
North American Rescue LLC.
Quantity
51,424 units
Distribution
Distribution throughout US and Puerto Rico OUS consignees in Australia, Czech Republic, Denmark, France, Germany, Ireland, Italy, Poland, and Switzerland
Recall date
September 29, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls