Cypress Medical Products LLC: McKesson 60CC Luer Lock Syringes Recalled for Lack of FDA Clearance

Agency Publication Date: August 29, 2024

Summary

Cypress Medical Products LLC is recalling approximately 24,693,200 McKesson 60CC Sterile Luer Lock Tip Syringes (Item No. 102-S60C) because they were distributed without required FDA clearance. These medical devices, manufactured within the last five years, may not meet federal safety and performance standards for medical use. The recall affects all lots beginning with the characters 'CLN' that are currently within their expiration date.

Risk

Using syringes that have not been cleared by the FDA poses a risk because their safety, effectiveness, and quality have not been verified by regulatory authorities. This could lead to potential device failure or inaccurate dosing during medical procedures.

What You Should Do

Check your medical supplies for McKesson Syringe 60CC, Luer Lock Tip, Sterile, with Item Number 102-S60C (also listed as Model No. 102-S60C).
Verify the lot number on the individual syringe packaging or the box (25 per box, 4 boxes per case); affected products have lot numbers beginning with the letters 'CLN'.
Confirm if the product is within its expiration date, as all unexpired lots beginning with 'CLN' are included in this recall.
Stop using the affected syringes immediately and set them aside to ensure they are not used for patient care or medical procedures.
Contact your healthcare provider or Cypress Medical Products LLC at their Richmond, VA location for further instructions regarding the return or disposal of these syringes and to discuss potential replacements or refunds.
For additional information or to report a problem, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Contact healthcare provider or manufacturer

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: McKesson Syringe 60CC, Luer Lock Tip, Sterile (Item No 102-S60C)

Model / REF:

102-S60C

Lot Numbers:

All lots beginning with alpha characters CLN

Date Ranges: Products manufactured within the last five years and within their expiration date

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95041

Status: Active

Manufacturer: Cypress Medical Products LLC

Sold By: authorized distributors; medical supply channels

Manufactured In: United States

Units Affected: 24,693,200 eaches (US)

Distributed To: Nationwide

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

Check your medical supplies for McKesson Syringe 60CC, Luer Lock Tip, Sterile, with Item Number 102-S60C (also listed as Model No. 102-S60C).

Verify the lot number on the individual syringe packaging or the box (25 per box, 4 boxes per case); affected products have lot numbers beginning with the letters 'CLN'.

Confirm if the product is within its expiration date, as all unexpired lots beginning with 'CLN' are included in this recall.

Stop using the affected syringes immediately and set them aside to ensure they are not used for patient care or medical procedures.

Contact your healthcare provider or Cypress Medical Products LLC at their Richmond, VA location for further instructions regarding the return or disposal of these syringes and to discuss potential replacements or refunds.

For additional information or to report a problem, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.