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Posted: 9/14/2021 12:31:34 PM EDT
I got a recall letter advising that certain lots of the ARS 10 ga decompression needle sold by North American Rescue are being recalled.

The recall is for units sold individually (not as part of a kit).

Here is a cut and paste of the letter:


This is to inform you of a product recall involving:
ZZ-0298 ARS DECOMPRESSION NEEDLE (10 GA)
LOTS W668NI, W693WF, W694ZH, W695DD, W696FN, W697IJ
UDI NUMBER 00842209108831
See product photograph (ENCLOSURE 1) for ease in identifying the product at user level.
North American Rescue (NAR) is voluntarily recalling product ZZ-0298 Lots W668NI, W693WF, W694ZH, W695DD, W696FN, and W697IJ.

We are recalling these products due to a manufacturing deviation which resulted in the device labeled with the incorrect Instruction for Use.
Affected product was shipped between January 20, 2021, and August 1, 2021. This product was shipped individually.
Below is a list of affected product and lot numbers. NAR Product Numbers and Lot Numbers Subject to Recall

Product Code:     ZZ-0298


Lot Numbers:

W668NI

W693WF

W694ZH

W695DD

W696FN

W697IJ


NOTE: Product affected by this recall was only shipped individually, and affected product was not included in any kits.

Immediately:

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.)
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