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Recall Observatory FDA recall evidence

Device product

ONE-LINK NON-DEHP Y-TYPE MICROBORE CATHETER EXTENSION SET NEEDLE-FREE IV CONNECTOR WITH NEUTRAL FLUID DISPLACEMENT

Z-0132-2016

May 21, 2015

Class II

Product summary

Firm
Baxter Healthcare Corp
Event
Event 71260
Status
Terminated
Classification
Class II
Quantity
23,600
Official record key
device-enforcement:Z-0132-2016

Official wording

Reason: Potential for a leak at the tubing to luer bond.

Code information: Code: 7N8371, Lots: UR15B16021 and UR15B23043

Distribution pattern: Domestic Only

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential for a leak at the tubing to luer bond.