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Recall Observatory FDA recall evidence

Device product

McKesson Insulin Syringe 0.3mL 31GX5/16 Item Numbers: 102-SN310C31516P Product Usage: Indication of Use: Injection of U-100 insulin only.

Z-0119-2019

September 04, 2018

Class II

Product summary

Firm
Cypress Medical Products LLC
Event
Event 81113
Status
Terminated
Classification
Class II
Quantity
400 cases
Official record key
device-enforcement:Z-0119-2019

Official wording

Reason: Small hole at the end of the syringe is impeding suction of liquid.

Code information: Lot Code: KSH0603

Distribution pattern: US Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Small hole at the end of the syringe is impeding suction of liquid.