Device 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.
Z-2252-2017
Product summary
- Event
- Event 77273
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7140 pieces
- Official record key
device-enforcement:Z-2252-2017
Official wording
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.
Code information: 11161099 11161729 11160990 11160912
Distribution pattern: Worldwide Distribution - US Nationwide in the countries of Belgium, Canada, Japan, Netherlands
Derived failure modes
-
Labeling or packaging
packaging defect