Z-2520-2021Class II

10 ga ARS Decompression Needle, Part Number ZZ-0298

Name: Z-2520-2021 10 ga ARS Decompression Needle, Part Number ZZ-0298
Creator: North American Rescue LLC.
Published: 2021-08-27
License: https://open.fda.gov/license/

North American Rescue LLC. / initiated 2021-08-27 / Terminated / root cause: labeling and UDI

FDA source

North American Rescue LLC. began a recall of 10 ga ARS Decompression Needle, Part Number ZZ-0298 on 2021-08-27. FDA classified it as Class II and gives the reason as "The device includes the incorrect Instructions for Use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2520-2021
Classification: Class II
Status: Terminated
Initiated: 2021-08-27
Posted: 2021-09-23
Terminated: 2024-01-19
Recalling firm: North American Rescue LLC.
Product: 10 ga ARS Decompression Needle, Part Number ZZ-0298
Product code: GAA Needle, Aspiration And Injection, Disposable
Reason for recall: The device includes the incorrect Instructions for Use.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: Consignees will be notified by 09/01/2021 via email with read/delivery receipt followed by First Class Mail letter. Additionally, the recall notification will be posted to the firm's website, www.marescue.com. Consignees are asked to do the following: 1. Examine your inventory and quarantine all product identified in this recall notification. 2. Discontinue all distribution or use of the recalled products identified in this recall notification. 3. Identify the ZZ-0298, with the aid of ENCLOSURE 1, and verify the recalled lot W668NI, W693WF, W694ZH, W695DD, W696FN, or W697IJ. UDI number 00842209108831. 4. Complete the Recall Return Response Form in ENCLOSURE 2, including all requested information, even if you do not have the recalled product. 5. Contact [email protected] and provide your completed Recall Return Response Form in order to receive a replacement and arrange for the return of the recalled lots. 6. For assistance completing these steps or questions regarding your order, please contact NAR Customer Service toll free at 1-888-689-6277. (Please have your customer order number available to reference.) This recall should be carried out to the user level. Your assistance is appreciated and necessary to prevent patient harm. If you have further distributed this product, please: 1. Identify your customers and immediately notify them of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. Please complete and return the Recall Return Response Form, in ENCLOSURE 2, as soon as possible. If you have any questions, call William Slevin at (864) 675-9800.
Quantity in commerce: 51,424 units
Distribution: Distribution throughout US and Puerto Rico OUS consignees in Australia, Czech Republic, Denmark, France, Germany, Ireland, Italy, Poland, and Switzerland
Product codes and lots: Part Number, ZZ-0298; Lots: o W668NI, W693WF, W694ZH, W695DD, W696FN, W697IJ

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2520-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2520-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-29	2021-09-23

Product code GAA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)