Z-0293-2020Class II

(1) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Small Straight, REF 046-1-200, 2...

Name: Z-0293-2020 (1) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Small Straight, REF 046-1-200, 2...
Creator: Argon Medical Devices, Inc
Published: 2018-10-16
License: https://open.fda.gov/license/

Argon Medical Devices, Inc / initiated 2018-10-16 / Terminated / root cause: manufacturing process

FDA source

Argon Medical Devices, Inc began a recall of (1) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Small Straight, REF 046-1-200, 2 clamps/package, 5 packages/box, 10 boxes/case, Sterile, Rx... on 2018-10-16. FDA classified it as Class II and gives the reason as "The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product". 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-0293-2020
Classification: Class II
Status: Terminated
Initiated: 2018-10-16
Posted: 2019-11-05
Terminated: 2021-06-15
Recalling firm: Argon Medical Devices, Inc
Product: (1) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Small Straight, REF 046-1-200, 2 clamps/package, 5 packages/box, 10 boxes/case, Sterile, Rx; (2) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Medium Straight, REF 046-1-300, 2 clamps per package, 5 packages/ shelf box, 10 shelf boxes/case (for a total of 50/2-clamp packages/case), Sterile, Rx; (3) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Medium Angled, REF 046-1-301, 2 clamps per package, 6 packages/box, 50 boxes/case, Sterile, Rx; and (4) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Large Angled, REF 046-1-401, 2 clamps per package, 5 packages/box, 50 boxes/case. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.
Product code: DRS Transducer, Blood-Pressure, Extravascular
Reason for recall: The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: The recalling firm began issuing letters dated 10/16/2018 on 10/16/2018 via registered mail identifying the issue and the action to be taken by the customer.
Quantity in commerce: Total number in recall for all products in dist: 49,130 units
Distribution: Distribution was nationwide. There was military/government distribution. Foreign distribution was made to Canada, Australia, the Netherlands, and Spain.
Product codes and lots: (1) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Small Straight, REF 046-1-200 - Lot number 11230432; (2) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Medium Straight, REF 046-1-300 - Lot numbers 11226690 and 11231581 (3) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Medium Angled, REF 046-1-301 - Lot number 11227669; (4) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Large Angled, REF 046-1-401 - Lot numbers 11228371 and 11230677.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0293-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0288-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-13	2019-11-05
Z-0289-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-13	2019-11-05
Z-0290-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-13	2019-11-05
Z-0291-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-13	2019-11-05
Z-0292-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-13	2019-11-05
Z-0293-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-13	2019-11-05
Z-0294-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-13	2019-11-05
Z-0295-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-13	2019-11-05
Z-0296-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-13	2019-11-05

Product code DRS

K771701Class IVessel-CludeMed General / cleared 1977-12-13

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)