CLASS II Device recall · Reported 29 Sep 2021 · FDA Enforcement Report
ARS Decompression Needle recalled by North American Rescue
North American Rescue is recalling ARS Decompression Needle, distributed in Puerto Rico. The recall was initiated on 27 Aug 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2520-2021
- FDA event ID
- 88603
- Recalling firm
- North American Rescue, Greer, SC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Aug 2021
- FDA classified
- 23 Sep 2021
- Reported
- 29 Sep 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Syringes & Needles
Timeline
| 27 Aug 2021 | Recall initiated by company | |
| 23 Sep 2021 | Classified by FDA | +27 days |
| 29 Sep 2021 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The device includes the incorrect Instructions for Use.
Product as listed by the FDA
10 ga ARS Decompression Needle, Part Number ZZ-0298
Where it was distributed
Distribution throughout US and Puerto Rico OUS consignees in Australia, Czech Republic, Denmark, France, Germany, Ireland, Italy, Poland, and Switzerland
Questions about this recall
Is ARS Decompression Needle recalled?
Yes. North American Rescue recalled ARS Decompression Needle on 27 Aug 2021. The recall is Class II and its status is Terminated. Recall number Z-2520-2021.
Why was it recalled?
The device includes the incorrect Instructions for Use.
Which lots are affected?
Part Number, ZZ-0298; Lots: o W668NI, W693WF, W694ZH, W695DD, W696FN, W697IJ
Where was it sold?
Distribution throughout US and Puerto Rico OUS consignees in Australia, Czech Republic, Denmark, France, Germany, Ireland, Italy, Poland, and Switzerland
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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