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Recall Observatory FDA recall evidence

Device product

CRN Crono Syringe CRN20 with 19G x 1 "Steel Needle"

Z-0099-2015

October 18, 2013

Class II

Product summary

Firm
Intra Pump Infusion Systems
Event
Event 66541
Status
Terminated
Classification
Class II
Quantity
25,440 pieces
Official record key
device-enforcement:Z-0099-2015

Official wording

Reason: Product has the potential to have a clear debris on the tip of the needle.

Code information: Product Code CRN20, lot numbers 14N02, 15E01, 15A02

Distribution pattern: Worldwide Distribution: US (nationwide) in states of CA, PA, MA, IL, OH and NY; and Internationally to Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Product has the potential to have a clear debris on the tip of the needle.