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.
Recall
- Recall Number
- Z-2252-2017
- Event Number
- 77273
- Firm
- Argon Medical Devices, Inc
- FEI Number
- 1625425
- Product Code
- GDR
- Status
- Terminated
- Root Cause
- Process design
- Initiated
- May 11, 2017
- Terminated
- January 25, 2018
- Address
- 1445 Flat Creek Rd, Athens, TX, 75751-5002
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.
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.
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.
Worldwide Distribution - US Nationwide in the countries of Belgium, Canada, Japan, Netherlands
7140 pieces