Z-2252-2017Class II

Clear Flashback Needle 7cm x 18G AMC/4; Clear Flashback Needle 2.5 cm x 21G AMC/4; Winged Arterial Needle 7cm...

Name: Z-2252-2017 Clear Flashback Needle 7cm x 18G AMC/4; Clear Flashback Needle 2.5 cm x 21G AMC/4; Winged Arterial Needle 7cm...
Creator: Argon Medical Devices, Inc
Published: 2017-05-11
License: https://open.fda.gov/license/

Argon Medical Devices, Inc / initiated 2017-05-11 / Terminated / root cause: manufacturing process

FDA source

Argon Medical Devices, Inc began a recall of 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... on 2017-05-11. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2252-2017
Classification: Class II
Status: Terminated
Initiated: 2017-05-11
Posted: 2017-06-06
Terminated: 2018-01-25
Recalling firm: Argon Medical Devices, Inc
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.
Product code: GDR Saw, Manual And Accessories
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.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: 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.
Quantity in commerce: 7140 pieces
Distribution: Worldwide Distribution - US Nationwide in the countries of Belgium, Canada, Japan, Netherlands
Product codes and lots: 11161099 11161729 11160990 11160912

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2252-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2252-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-14	2017-06-06

Product code GDR

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)