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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices

VYGON, CORMIX, SECURE, and Imed IV Bags Recalled for Leaks During Filling

Agency Publication Date: November 8, 2024
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Summary

The Metrix Company is recalling 20,364 empty IV bags sold under the VYGON, CORMIX, SECURE, and Imed Products brands. These single-use plastic pouches, designed to contain intravenous fluids, were found to leak during the filling process. No injuries or incidents have been reported to date, but the company initiated the recall after discovering the defect.

Risk

Leaking IV bags can lead to the loss of critical medication or fluids and may allow contaminants into the sterile container. This poses a risk of infection or inadequate dosing for patients receiving intravenous therapy.

What You Should Do

  1. This recall affects 20,364 empty EVA IV containers with 2 ports sold under the brands VYGON, CORMIX, SECURE, and Imed Products. These plastic pouches are available in sizes ranging from 50 mL to 1000 mL.
  2. Identify your product by looking for the REF (model) number and lot number on the packaging. Affected REF numbers include CMS-9601, CMS-9602, MS64040, MS64045, MS64050, 66040, 66041, 66042, 66043, 66045, 66050, 66055, IM38040, IM68045, IM68050, and IM68055. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.
  4. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: VYGON 100 mL EMPTY EVA CONTAINER With 2 Ports
Variants: 100 mL
Model / REF:
CMS-9601
Lot Numbers:
62040-A8375
62040-A8432
UDI:
00812496011008

An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.

Product: VYGON 250 mL EMPTY EVA CONTAINER With 2 Ports
Variants: 250 mL
Model / REF:
CMS-9602
Lot Numbers:
62045-A8339
62045-A8376
62045-A8467
UDI:
00812496011022

An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.

Product: CORMIX 150 mL EMPTY EVA CONTAINER With 2 Ports
Variants: 150 mL
Model / REF:
MS64040
Lot Numbers:
64040-A8313
64040-A8340
64040-A8365
64040-A8437
UDI:
00812496011114

An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.

Product: CORMIX 250 mL EMPTY EVA CONTAINER With 2 Ports
Variants: 250 mL
Model / REF:
MS64045
Lot Numbers:
64045-A8305
64045-A8341
64045-A8366
64045-A8377
64045-A8405
64045-A8411
64045-A8447
64045-A8469
64045-A8485
UDI:
00812496011121

An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.

Product: CORMIX 500 mL EMPTY EVA CONTAINER With 2 Ports
Variants: 500 mL
Model / REF:
MS64050
Lot Numbers:
64050-A8293
64050-A8406
64050-A8421
64050-A8452
64050-A8470
UDI:
00812496011138

An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.

Product: SECURE 100 mL EMPTY EVA CONTAINER With 2 Ports
Variants: 100 mL
Model / REF:
66040
Lot Numbers:
66040-A8314
66040-A8368
66040-A8417
66040-A8482
UDI:
00812496011541

An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.

Product: SECURE 100 mL EMPTY EVA CONTAINER With 2 Ports (Bulk Packed)
Variants: 100 mL, Bulk Packed
Model / REF:
66041
Lot Numbers:
66041-A8296
66041-A8343
66041-A8386
66041-A8418
66041-A8433
UDI:
50812496011553

An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.

Product: SECURE 50 mL EMPTY EVA CONTAINER With 2 Ports
Variants: 50 mL
Model / REF:
66042
Lot Numbers:
66042-A8297
66042-A8422
66042-A8459
UDI:
00812496011565

An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.

Product: SECURE 50 mL EMPTY EVA CONTAINER With 2 Ports (Bulk Packed)
Variants: 50 mL, Bulk Packed
Model / REF:
66043
Lot Numbers:
66043-A8298
UDI:
50812496011577

An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.

Product: SECURE 250 mL EMPTY EVA CONTAINER With 2 Ports
Variants: 250 mL
Model / REF:
66045
Lot Numbers:
66045-A8308
66045-A8334
66045-A8360
66045-A8382
66045-A8419
UDI:
00812496011589

An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.

Product: SECURE 500 mL EMPTY EVA CONTAINER With 2 Ports
Variants: 500 mL
Model / REF:
66050
Lot Numbers:
66050-A8335
66050-A8409
66050-A8460
UDI:
00812496011596

An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.

Product: SECURE 1000 mL EMPTY EVA CONTAINER With 2 Ports
Variants: 1000 mL
Model / REF:
66055
Lot Numbers:
66055-A8336
66055-A8483
UDI:
00812496011602

An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.

Product: Imed Products Imed EVA BAG, 150 mL, 2-PORTS
Variants: 150 mL
Model / REF:
IM38040
Lot Numbers:
68040-A8318
68040-A8408
68040-A8441
68040-A8474
UDI:
00812496011305

An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.

Product: Imed Products Imed EVA BAG, 250 mL, 2-PORTS
Variants: 250 mL
Model / REF:
IM68045
Lot Numbers:
68045-A8289
68045-A8319
68045-A8347
68045-A8390
68045-A8434
UDI:
00812496011312

An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.

Product: Imed Products Imed EVA BAG, 500 mL, 2-PORTS
Variants: 500 mL
Model / REF:
IM68050
Lot Numbers:
68050-A8320
68050-A8435
68050-A8476
UDI:
00812496011329

An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.

Product: Imed Products Imed EVA BAG, 1000 mL, 2-PORTS
Variants: 1000 mL
Model / REF:
IM68055
Lot Numbers:
68055-A8362
UDI:
00853155008427

An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95499
Status: Active
Manufacturer: The Metrix Company
Sold By: The Metrix Company; Medical Supply Distributors
Manufactured In: United States
Units Affected: 16 products (288 cases of 50 units; 384 cases of 50 units; 1920 cases of 50 units; 3456 cases of 50 units; 1440 cases of 50 units; 2229 cases of 50 units; 2549 cases of 50 units; 1013 cases of 50 units; 83 cases of 50 units; 2921 cases of 50 units; 1020 cases of 50 units; 277 cases of 50 units; 768 units; 1056 cases of 50 units; 864 cases of 50 units; 96 cases of 50 units)
Distributed To: Texas, Illinois, Ohio, Pennsylvania, Washington, Maryland, Utah, California, Massachusetts, Michigan, Florida, Puerto Rico

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.