FDA Medical Device Recalls (openFDA)
North American Rescue LLC.: 10 ga ARS Decompression Needle, Part Number ZZ-0298
- Recall number
- Z-2520-2021
- Recalling firm
- North American Rescue LLC.
- Product
- 10 ga ARS Decompression Needle, Part Number ZZ-0298
- Status
- Terminated
- Initiated
- 2021-08-27
- Posted
- not on file
- Terminated
- 2024-01-19
- Reason
- The device includes the incorrect Instructions for Use.
- 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 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
- 51,424 units
- Distribution
- Distribution throughout US and Puerto Rico OUS consignees in Australia, Czech Republic, Denmark, France, Germany, Ireland, Italy, Poland, and Switzerland
- Lot, serial or model codes
- Part Number, ZZ-0298; Lots: o W668NI, W693WF, W694ZH, W695DD, W696FN, W697IJ
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GAA
- Firm FEI
- 3005034064
- Firm city
- Greer
- Firm state
- SC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28