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U.S. Department of Health and Human Services

Class 2 Device Recall ARS Decompression Needle

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  Class 2 Device Recall ARS Decompression Needle see related information
Date Initiated by Firm August 27, 2021
Create Date September 23, 2021
Recall Status1 Terminated 3 on January 19, 2024
Recall Number Z-2520-2021
Recall Event ID 88603
Product Classification Needle, aspiration and injection, disposable - Product Code GAA
Product 10 ga ARS Decompression Needle, Part Number ZZ-0298
Code Information Part Number, ZZ-0298; Lots: o W668NI, W693WF, W694ZH, W695DD, W696FN, W697IJ
Recalling Firm/
Manufacturer
North American Rescue LLC.
35 Tedwall Ct
Greer SC 29650-4791
For Additional Information Contact William Slevin
864-675-9800
Manufacturer Reason
for Recall
The device includes the incorrect Instructions for Use.
FDA Determined
Cause 2
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 recalls@narescue.com 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
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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