Smiths Medical ASD, Inc.: Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringes

Agency Publication Date: January 8, 2014

Affected Products

Product: Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 1.0ml 29g x 1/2 in Reference: 4429-1 Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringes are sterile, latex free, non-pyrogenic, single use devices intended for injection of U-100 insulin only. The syringe has an integral rotational needle protection sheath.

Lot Numbers: 2340530, 2344163, 2353091, 2357317, 2377316

Lot Numbers:

Numbers

Product: Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 0.3ml 29g x 1/2 in Reference: 4429-3 Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringes are sterile, latex free, non-pyrogenic, single use devices intended for injection of U-100 insulin only. The syringe has an integral rotational needle protection sheath.

Lot Number: 2357318

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Number

Product: Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 0.5ml 29g x 1/2 in Reference: 4429-5 Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringes are sterile, latex free, non-pyrogenic, single use devices intended for injection of U-100 insulin only. The syringe has an integral rotational needle protection sheath.

Lot Numbers: 2330832, 2336493, 2348708, 2353094, 2357319

Lot Numbers:

Numbers

Product: Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 1.0ml 29g x 1/2 in Distributed by: Cardinal Health, Dublin, OH (Co-Brand) Reference: ED012905-IN Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringes are sterile, latex free, non-pyrogenic, single use devices intended for injection of U-100 insulin only. The syringe has an integral rotational needle protection sheath.

Lot Numbers: 2356156, 2358706

Lot Numbers:

Numbers

Product: Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 0.5ml 29g x 1/2 in. Distributed by: Cardinal Health, Dublin, OH (Co-Brand) Reference: ED052905IN Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringes are sterile, latex free, non-pyrogenic, single use devices intended for injection of U-100 insulin only. The syringe has an integral rotational needle protection sheath.

Lot Numbers: 2358702

Lot Numbers:

Numbers

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 67034

Status: Resolved

Manufacturer: Smiths Medical ASD, Inc.

Manufactured In: United States

Units Affected: 5 products (363015; 93700; 506925; 108000; 54000)

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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 · Raw API Response

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Affected Products

Lot Numbers: 2340530, 2344163, 2353091, 2357317, 2377316

Lot Numbers:

Numbers

Lot Number: 2357318

Lot Numbers:

Number

Lot Numbers: 2330832, 2336493, 2348708, 2353094, 2357319

Lot Numbers:

Numbers

Lot Numbers: 2356156, 2358706

Lot Numbers:

Numbers

Lot Numbers: 2358702

Lot Numbers:

Numbers