Clear Flashback Needle 7cm x 18G AMC/4; Clear Flashback Needle 2.5 cm x 21G AMC/4; Winged Arterial Needle 7cm x 18G AMC/4; Clear Flashback Needle 7 cm x 19G AMC/4 Usage: Argon Arterial Access Needles are designed to provide vascular access for the percutaneous introduction of a guidewire.
Reported: June 14, 2017 Initiated: May 11, 2017 #Z-2252-2017
Product Description
Clear Flashback Needle 7cm x 18G AMC/4; Clear Flashback Needle 2.5 cm x 21G AMC/4; Winged Arterial Needle 7cm x 18G AMC/4; Clear Flashback Needle 7 cm x 19G AMC/4 Usage: Argon Arterial Access Needles are designed to provide vascular access for the percutaneous introduction of a guidewire.
Reason for Recall
Argon Medical has received a complaint from one of their distributors of a potential packaging defect. The product is sealed in a pouch and the defect if present shows as a potential void or unsealed edge of the pouch.
Details
- Recalling Firm
- Argon Medical Devices, Inc
- Units Affected
- 7140 pieces
- Distribution
- Worldwide Distribution - US Nationwide in the countries of Belgium, Canada, Japan, Netherlands
- Location
- Athens, TX
Frequently Asked Questions
What product was recalled? ▼
Clear Flashback Needle 7cm x 18G AMC/4; Clear Flashback Needle 2.5 cm x 21G AMC/4; Winged Arterial Needle 7cm x 18G AMC/4; Clear Flashback Needle 7 cm x 19G AMC/4 Usage: Argon Arterial Access Needles are designed to provide vascular access for the percutaneous introduction of a guidewire.. Recalled by Argon Medical Devices, Inc. Units affected: 7140 pieces.
Why was this product recalled? ▼
Argon Medical has received a complaint from one of their distributors of a potential packaging defect. The product is sealed in a pouch and the defect if present shows as a potential void or unsealed edge of the pouch.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 14, 2017. Severity: Moderate. Recall number: Z-2252-2017.
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