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Recall Observatory FDA recall evidence

Device product

General Purpose Syringe McKesson 60 mL Luer Lock Tip Without Safety, Catalog Number 869662, McKesson Brand Catalog Number: 102-S60C

Z-3154-2024

August 06, 2024

Class II

Product summary

Firm
Cypress Medical Products LLC
Event
Event 95223
Status
Ongoing
Classification
Class II
Quantity
3 Boxes (25 per box, 75 total units)
Official record key
device-enforcement:Z-3154-2024

Official wording

Reason: 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.

Code information: UDI-DI: 20612479170302;

Distribution pattern: US Nationwide distribution in the states of CA, NV, NY.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.