Recall Z-2252-2017— Argon Medical Devices, Inc
Class II · Terminated
Class II FDA medical device recall by Argon Medical Devices, Inc, initiated 2017-05-11, terminated 2018-01-25. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: 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..
- Recalling firm
- Argon Medical Devices, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-05-11
- Terminated
- 2018-01-25
- Firm location
- Athens, TX, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.