Medium RiskFDA Device

Cardinal Health 200, LLC: Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product

Agency Publication Date: July 23, 2019

Affected Products

Product: Monoject Standard Hypodermic Needle, 14 G x 1-1/2" Item code: 8881200011

Lot Number: 904218, 904918, 906329

Lot Numbers:

Number

Product: Monoject Standard Hypodermic Needle Item code: 8881200029

Lot Number: 904956

Lot Numbers:

Number

Product: Monoject Standard Hypodermic Needle, 16 G x 1-1/2" Item code: 8881200037

Lot Number:904212, 905612, 907002

Lot Numbers:

Number

Product: Monoject Standard Hypodermic Needle, 16 G x 1-1/2" Item code:8881200045

Lot Number: 905613

Lot Numbers:

Number

Product: Monoject Standard Hypodermic Needle, 18 G x 1-1/2" Item code: 8881200078

Lot Number: 907007

Lot Numbers:

Number

Product: Monoject Standard Hypodermic Needle, 27 G x 1-1/4" Item code: 8881200508

Lot Number: 904901

Lot Numbers:

Number

Product: Monoject Standard Hypodermic Needle, 20 G x 1-1/2" bulk Item code: 8881200664

Lot Number: 905657, 906327, 906341

Lot Numbers:

Number

Product: Monoject 201 Vet Pak Hypodermic Needle, 22 ga x 1-1/2" Item code: 8881201456

Lot Number: 909117

Lot Numbers:

Number

Product: Monoject 201 Vet Pak Hypodermic Needle, 20 ga x 1-1/2" Item code: 8881201498

Lot Number: 905611

Lot Numbers:

Number

Product: Monoject 201 Vet Pak Hypodermic Needle, 19 ga x 1-1/2 Item code: 8881201522

Lot Number: 905662

Lot Numbers:

Number

Product: Monoject 201 Vet Pak Hypodermic Needle, 18 ga x 1-1/2 Item code: 8881201548

Lot Number: 904219, 904220, 907710

Lot Numbers:

Number

Product: Monoject" 201 Vet Pak Hypodermic Needle, 16 ga x 1-1/2 Item code: 8881201654

Lot Number: 902108

Lot Numbers:

Number

Product: Monoject Blunt Cannula, 15 G x 1-1/2" (1.829 mm x 3.8 cm) Item code: 8881202314

Lot Number: 905659, 905660, 906343

Lot Numbers:

Number

Product: Monoject Blunt Cannula, 16 G x 1-1/2" (1.651 mm x 3.8 cm) Item code: 8881202322

Lot Number: 902110, 902111

Lot Numbers:

Number

Product: Monoject Blunt Cannula, 19 G x 1-1/2" (1.067 mm x 3.8 cm) Item code: 8881202355

Lot Number: 905617, 905618, 905619, 905620, 907004, 907005

Lot Numbers:

Number

Product: Monoject Blunt Cannula, 20 G x 1-1/2" (0.902 mm x 3.8 cm) Item code: 8881202363

Lot Number: 907734

Lot Numbers:

Number

Product: Monoject Blunt Cannula, 22 G x 1-1/2" (0.711 mm x 3.8 cm) Item code: 8881202389

Lot Number: 903530

Lot Numbers:

Number

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 82927

Status: Resolved

Manufacturer: Cardinal Health 200, LLC

Manufactured In: United States

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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This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

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 · 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.

Affected Products

Product: Monoject Standard Hypodermic Needle, 14 G x 1-1/2" Item code: 8881200011

Lot Number: 904218, 904918, 906329

Lot Numbers:

Number

Product: Monoject Standard Hypodermic Needle Item code: 8881200029

Lot Number: 904956

Lot Numbers:

Number

Product: Monoject Standard Hypodermic Needle, 16 G x 1-1/2" Item code: 8881200037

Lot Number:904212, 905612, 907002

Lot Numbers:

Number

Product: Monoject Standard Hypodermic Needle, 16 G x 1-1/2" Item code:8881200045

Lot Number: 905613

Lot Numbers:

Number

Product: Monoject Standard Hypodermic Needle, 18 G x 1-1/2" Item code: 8881200078

Lot Number: 907007

Lot Numbers:

Number

Product: Monoject Standard Hypodermic Needle, 27 G x 1-1/4" Item code: 8881200508

Lot Number: 904901

Lot Numbers:

Number

Product: Monoject Standard Hypodermic Needle, 20 G x 1-1/2" bulk Item code: 8881200664

Lot Number: 905657, 906327, 906341

Lot Numbers:

Number

Product: Monoject 201 Vet Pak Hypodermic Needle, 22 ga x 1-1/2" Item code: 8881201456

Lot Number: 909117

Lot Numbers:

Number

Product: Monoject 201 Vet Pak Hypodermic Needle, 20 ga x 1-1/2" Item code: 8881201498

Lot Number: 905611

Lot Numbers:

Number

Product: Monoject 201 Vet Pak Hypodermic Needle, 19 ga x 1-1/2 Item code: 8881201522

Lot Number: 905662

Lot Numbers:

Number

Product: Monoject 201 Vet Pak Hypodermic Needle, 18 ga x 1-1/2 Item code: 8881201548

Lot Number: 904219, 904220, 907710

Lot Numbers:

Number

Product: Monoject" 201 Vet Pak Hypodermic Needle, 16 ga x 1-1/2 Item code: 8881201654

Lot Number: 902108

Lot Numbers:

Number

Product: Monoject Blunt Cannula, 15 G x 1-1/2" (1.829 mm x 3.8 cm) Item code: 8881202314

Lot Number: 905659, 905660, 906343

Lot Numbers:

Number

Product: Monoject Blunt Cannula, 16 G x 1-1/2" (1.651 mm x 3.8 cm) Item code: 8881202322

Lot Number: 902110, 902111

Lot Numbers:

Number

Product: Monoject Blunt Cannula, 19 G x 1-1/2" (1.067 mm x 3.8 cm) Item code: 8881202355

Lot Number: 905617, 905618, 905619, 905620, 907004, 907005

Lot Numbers:

Number

Product: Monoject Blunt Cannula, 20 G x 1-1/2" (0.902 mm x 3.8 cm) Item code: 8881202363

Lot Number: 907734

Lot Numbers:

Number

Product: Monoject Blunt Cannula, 22 G x 1-1/2" (0.711 mm x 3.8 cm) Item code: 8881202389

Lot Number: 903530

Lot Numbers:

Number