Data Foundry

Medical device recalls 2017

Clear Flashback Needle 7cm x 18G AMC/4 — Class II medical device recall Z-2252-2017

Terminated recall by Argon Medical Devices, Inc, reported 2017-06-14, distributed nationwide. Argon Medical has received a complaint from one of their distributors of a potential packaging defect. The pro

Recall numberZ-2252-2017
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmArgon Medical Devices, Inc, Athens, TX, United States
Recall initiated2017-05-11
Classified2017-06-06
Reported by FDA2017-06-14
Terminated2018-01-25
DistributedNationwide (US)
Countries outside the USBE, CA, JP, NL
Quantity7,140 units
Reason classespackaging

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 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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2252-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.