Z-3154-2024Class II

General Purpose Syringe McKesson 60 mL Luer Lock Tip Without Safety, Catalog Number 869662, McKesson Brand...

Name: Z-3154-2024 General Purpose Syringe McKesson 60 mL Luer Lock Tip Without Safety, Catalog Number 869662, McKesson Brand...
Creator: Cypress Medical Products LLC
Published: 2024-08-06
License: https://open.fda.gov/license/

Cypress Medical Products LLC / initiated 2024-08-06 / Open, Classified / root cause: manufacturing process

FDA source

Cypress Medical Products LLC began a recall of General Purpose Syringe McKesson 60 mL Luer Lock Tip Without Safety, Catalog Number 869662, McKesson Brand Catalog Number: 102-S60C on 2024-08-06. FDA classified it as Class II and gives the reason as "The syringes that were inadvertently shipped from the Distribution Center. This product was on quarantine because FDA has stated that these syringes lack FDA clearance and were inadvertently shipped due to an internal...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-3154-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-08-06
Posted: 2024-09-16
Recalling firm: Cypress Medical Products LLC
Product: General Purpose Syringe McKesson 60 mL Luer Lock Tip Without Safety, Catalog Number 869662, McKesson Brand Catalog Number: 102-S60C
Product code: FMF Syringe, Piston
Reason for recall: The syringes that were inadvertently shipped from the Distribution Center. This product was on quarantine because FDA has stated that these syringes lack FDA clearance and were inadvertently shipped due to an internal order processing error.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: An Urgent Product Recall Notification letter dated 8/6/24 was sent to customers. Actions to be Taken 1. Immediately quarantine and discontinue use of any product matching the affected items and lot numbers listed above. Affected items should be destroyed on location per appropriate local, state, and federal disposal requirements. 2. Please complete and return the enclosed response form (Attachment #1) as soon as possible, even if you do not have any product on hand or have already consumed the product. Return completed form to [email protected]. 3. If you have further distributed this product to end users, please notify them immediately of this urgent product recall and ask them to segregate and quarantine this product immediately. You are encouraged to include a copy of this notification letter in your communication with any of these end users. If you have questions regarding this notification, please contact McKesson directly by phone at (800) 688-8840 or email [email protected]. Representatives are available Monday Friday, 8:00 am 5:00 pm PST.
Quantity in commerce: 3 Boxes (25 per box, 75 total units)
Distribution: US Nationwide distribution in the states of CA, NV, NY.
Product codes and lots: UDI-DI: 20612479170302;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3154-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3154-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-25	2024-09-16

Product code FMF

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)