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Recall Observatory FDA recall evidence

Device product

Bardex Lubricath 3-Way 75cc Continuous Irrigation Foley Catheter (Creevy), 22Fr. Rx (01267522)

Z-2064-2018

December 13, 2017

Class II

Product summary

Firm
C.R. Bard, Inc.
Event
Event 80150
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-2064-2018

Official wording

Reason: Foley Catheter with Incorrect Retainer Cap Print

Code information: Catalog # 01267522 Lot #'s: NGBR0383 and NGBR2129

Distribution pattern: FL, NY, MN and TX Canada, Japan and Taiwan

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Foley Catheter with Incorrect Retainer Cap Print