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Recall Observatory FDA recall evidence

Device product

CarePoint 60 mL Syringe Without Needle, REF: 04-7560

Z-0478-2023

September 03, 2020

Class II

Product summary

Firm
Allison Medical, Inc.
Event
Event 91092
Status
Completed
Classification
Class II
Quantity
2,004 Boxes
Official record key
device-enforcement:Z-0478-2023

Official wording

Reason: Syringe without needle may have a green substance on the plunger. Substance found to be nontoxic but its effect on drug potency or interaction is unknown.

Code information: UDI-DI: 00786227756059, REF/Lot: 04-7560/ 80522

Distribution pattern: US: IA, LA, MS, FL, PR; OUS: BARBADOS

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Syringe without needle may have a green substance on the plunger. Substance found to be nontoxic but its effect on drug potency or interaction is unknown.