The Recall Desk
HighFDA (Devices)·Z-0290-2020·Announced 2019-11-13

Argon Medical Devices Recalls Stopcocks Due to Incomplete Pouch Seals

Argon Medical Devices is recalling specific stopcock products because incomplete pouch seals may cause a loss of sterility.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a loss of sterility in medical devices, which poses a risk of harm (infection) even though no specific injuries are reported in the source text.

Plain-English summary

Argon Medical Devices, Inc. is recalling six specific stopcock products, including 4-Way, 1-Way, and 3-Way stopcocks, due to a potential defect in the packaging. The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.

The recall involves a total of 49,130 units. Distribution was nationwide, including military and government channels, as well as foreign distribution to Canada, Australia, the Netherlands, and Spain. The affected products are sterile, prescription medical devices manufactured by Argon Medical Devices, Inc. in Athens, TX.

Healthcare facilities and consumers should check their inventory for the specific reference numbers and lot numbers listed in the official recall notice. If the products are found, they should be removed from use and returned to the manufacturer or the appropriate distributor for credit or replacement.

The recalled product

Product
(1) Argon Medical Devices Stopcocks, Clear 4-Way Stopcock w/Male Luer Lock, REF 041210002A, 25/box, Sterile, Rx; (2) Argon Medical Devices Stopcocks, 1-Way w/Male Luer Lock, REF 041216000A, 25/box, Sterile, Rx; (3) Argon Medical Devices Stopcocks, Double 4-Way Stopcock w/Ma
Manufacturer
Argon Medical Devices, Inc
Category
Medical Device — Stopcocks
Hazard
Affected units
49,130

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • (1) Argon Medical Devices Stopcocks
  • Clear 4-Way Stopcock w/Male Luer Lock
  • REF 041210002A-Lot numbers 11226656 and 11228887
  • (2) Argon Medical Devices Stopcocks
  • 1-Way w/Male Luer Lock
  • REF 041216000A - Lot numbers 11226187
  • 11229619
  • and 11227967
  • (3) Argon Medical Devices Stopcocks
  • Double 4-Way Stopcock w/Male Luer Lock
  • REF 041220001A - Lot numbers 11228888
  • 11230598
  • (4) Argon Medical Devices Stopcocks
  • Clear 4-Way Stopcock w/Rotating Male Luer Lock
  • REF 041240002A - Lot number 11228245
  • (5) Argon Medical Devices Stopcocks
  • North Carolina Baptist Hospital
  • Winston-Salem
  • NC
  • REF 042597300A - Lot number 11232206

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 9 recalled by Argon Medical Devices, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 9 products in this recall →

Related recalls

Same manufacturer · Argon Medical Devices, Inc

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Same hazard · loss of sterility

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