Home / Recalls / North American Rescue LLC. / Z-2520-2021

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 August 27, 2021 and is designated Class II. Reason for recall: The device includes the incorrect Instructions for Use. The recall status is terminated (terminated January 19, 2024). Affected quantity: 51,424 units.

Recall Details

Product Type: Devices
Report Date: September 29, 2021
Initiation Date: August 27, 2021
Termination Date: January 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

Other recalls by North American Rescue LLC.

Z-1947-2026 Class I — AIDBAGs are first aid kits of convenience composed of individually labeled devic (March 27, 2026)
Z-2637-2025 Class II — JUNCTIONAL EMERGENCY TREATMENT TOOL (JETT), REF: 30-0088, a component inside kit (July 1, 2025)
Z-3018-2020 Class II — 4 In. Flat Responder Emergency Trauma Dressing part number 30-0171, packaged in (August 21, 2020)
D-0180-2017 Class II — Amphibious Trauma Kit - Product Code 85-0639, North American Rescue (September 27, 2016)
D-0178-2017 Class II — Advance Trauma Kit - Product Code 85-0742, 85-0746, 85-0745, 85-0639, 85-0744, 8 (September 27, 2016)
D-0183-2017 Class II — USCG Boat Response Kit - Product Code 80-0353, North American Rescue (September 27, 2016)
D-0181-2017 Class II — Mini Resupply Trauma Kit - Product Code 85-0835, North American Rescue (September 27, 2016)
D-0177-2017 Class II — Range Trauma Kit - Product Code 85-1274, North American Rescue (September 27, 2016)
D-0175-2017 Class II — Range Trauma Kit Hardcase - Product Code 85-0889, North American Rescue (September 27, 2016)
D-0182-2017 Class II — Aid Backpack Kit - Product Code 85-0917, North American Rescue (September 27, 2016)