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.
This recall has been terminated (originally issued May 11, 2017).
- Company
- Argon Medical Devices, Inc
- Recall Initiated
- May 11, 2017
- Terminated
- January 25, 2018
- Recall Number
- Z-2252-2017
- Quantity
- 7140 pieces
- Firm Location
- Athens, TX
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide Distribution - US Nationwide in the countries of Belgium, Canada, Japan, Netherlands
Lot / Code Info
11161099 11161729 11160990 11160912
Root Cause
Process design
Action Taken
Argon Medical Devices, Inc. is sending an Urgent Medical Device Recall letter by registered mail to the affected customer/hospital/distributor. Customers are instructed to inspect and quarantine and return any affected product remaining at their facility utilizing the instruction on the Recall Response Form.