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Recall Observatory FDA recall evidence

Device product

Pressure Injectable Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter and Sharps Safety Features; Product Code: ASK-15703-PRWJ; Exp. Dates Feb 2018- Nov 2018

Z-0651-2018

October 17, 2017

Class II

Product summary

Firm
Arrow International Inc
Event
Event 79197
Status
Terminated
Classification
Class II
Quantity
5,926 total
Official record key
device-enforcement:Z-0651-2018

Official wording

Reason: These finished good kits may contain the incorrect Springwire Guide (SWG).

Code information: Lot number: 13F17C0400

Distribution pattern: Distribution US Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    These finished good kits may contain the incorrect Springwire Guide (SWG).