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Z-2520-2021 Class II Terminated

Recalled by North American Rescue LLC. — Greer, SC

FDA device recall Z-2520-2021 was initiated by North American Rescue LLC. on Aug 27, 2021 and is designated Class II. Reason for recall: The device includes the incorrect Instructions for Use. The recall status is terminated (terminated Jan 19, 2024). Affected quantity: 51,424 units.

Recall Details

Product Type: Devices
Report Date: Sep 29, 2021
Initiation Date: Aug 27, 2021
Termination Date: Jan 19, 2024
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 51,424 units

Product Description

10 ga ARS Decompression Needle, Part Number ZZ-0298

Reason for Recall

The device includes the incorrect Instructions for Use.

Distribution Pattern

Distribution throughout US and Puerto Rico OUS consignees in Australia, Czech Republic, Denmark, France, Germany, Ireland, Italy, Poland, and Switzerland

Code Information

Part Number, ZZ-0298; Lots: o W668NI, W693WF, W694ZH, W695DD, W696FN, W697IJ

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