🔍 RecallPedia

10 ga ARS Decompression Needle, Part Number ZZ-0298

Class I - Dangerous
🏥 Medical Devices Recalled: August 27, 2021 North American Rescue Surgical Instruments

What Should You Do?

  1. Check if you have this product:
    Part Number, ZZ-0298; Lots: o W668NI, W693WF, W694ZH, W695DD, W696FN, W697IJ
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
North American Rescue LLC.
Reason for Recall:
The device includes the incorrect Instructions for Use.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

10 ga ARS Decompression Needle, Part Number ZZ-0298

Product Codes/Lot Numbers:

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

Distribution:

Distributed in: US

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2520-2021

Related Recalls

JUNCTIONAL EMERGENCY TREATMENT TOOL (JETT), REF: 30-0088, a component inside kits: KIT, TCCC Training- Complete (Modules 1-3), REF: 85-0550; KIT, TCCC MODULE ONE - SKILLS, REF: 85-0519; KIT, MULTI MISSION EXPEDITIONARY RESPONSE - MMERK, REF: 85-2420; KIT, TCCC SKILLS/IFAK COMBO, REF: 85-0740, KIT, TCCC/TECC MODULE ONE SKILLS REFILL, REF: 85-1900

North American Rescue

Class I - Dangerous

Device used for unilateral or bilateral occlusion of blood flow to the lower limbs has a potential manufacturing defect that may compromise the structural integrity of the device and device performance during use.

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North American Rescue

Class I - Dangerous

Lack of sterility assurance of the 30-0171

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