RegWardenFDA facility compliance records
Recall

Class II — C.R. Bard, Inc.

Recalling firmC. R. Bard, Inc.
Registered facilityView this company's 19 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusTerminated
ReasonActivity and quantity of seeds sent in shipments were incorrect.
ProductI-125 CE Marked QuickLink Cartridges; Sterile; Bard Brachysource Radioactive Seeds in QuickLink Cartridges Indicated for permanent interstitial treatment of selected localized tumors such as: head and neck, lung, pancreas, and early stage prostate. Implants are indicated to treat residual tumors following completion of a course of external radiation therapy and for recurrent tumors.
Quantity134 seeds
DistributionBelgium & South Africa.
Initiated2016-12-09
Classified2017-12-20
Terminated2020-04-24
Recall numberZ-0267-2018
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — C.R. Bard, Inc. (Z-0267-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/77439/

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