Medications & Supplements/Prescription Drugs

PARAGARD T380A Intrauterine Contraceptives Recalled for Non-Sterility

Agency Publication Date: February 14, 2022

Summary

CooperSurgical, Inc. has recalled 48,645 cartons of PARAGARD T380A (intrauterine copper contraceptive) because the product may not be sterile. The recall affects Lot 517001 with an expiration date of January 2024. While no injuries or incidents have been reported, using a non-sterile device poses a risk of infection. If you have health concerns, you should contact your healthcare provider or pharmacist immediately.

Risk

The product was found to be non-sterile, which can lead to serious infections or other health complications when the device is inserted. No incidents or injuries have been reported to date for this specific lot.

What You Should Do

This recall affects PARAGARD T380A (intrauterine copper contraceptive) packaged in single-unit cartons (NDC 51285-204-01) with Lot Number 517001 and an expiration date of 1/2024.
Check the lot number and expiration date printed on the product carton or the Tyvek polyethylene pouch to see if your unit is affected.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: PARAGARD T380A (intrauterine copper contraceptive)

Variants: 1 unit per carton, Includes insertion tube and solid white rod, Tyvek polyethylene pouch

Lot Numbers:

517001 (Exp 1/2024)

NDC:

51285-204-01

Rx Only. Manufactured by Teva Women's Health Inc. a subsidiary of Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89462

Status: Resolved

Manufacturer: CooperSurgical, Inc

Sold By: Healthcare providers; Pharmacies

Manufactured In: United States

Units Affected: 48,645 cartons

Distributed To: Nationwide

Agency Last Updated: February 6, 2023

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.

Find an Attorney

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.

Summary

What You Should Do

This recall affects PARAGARD T380A (intrauterine copper contraceptive) packaged in single-unit cartons (NDC 51285-204-01) with Lot Number 517001 and an expiration date of 1/2024.

Check the lot number and expiration date printed on the product carton or the Tyvek polyethylene pouch to see if your unit is affected.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: PARAGARD T380A (intrauterine copper contraceptive)

Variants: 1 unit per carton, Includes insertion tube and solid white rod, Tyvek polyethylene pouch

Lot Numbers:

517001 (Exp 1/2024)

NDC:

51285-204-01

Rx Only. Manufactured by Teva Women's Health Inc. a subsidiary of Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.