Recall Z-0267-2018— C.R. Bard, Inc.

Name: FDA recall Z-0267-2018
Creator: U.S. Food and Drug Administration
Published: 2016-12-09

Class II · Terminated

Class II FDA medical device recall by C.R. Bard, Inc., initiated 2016-12-09, terminated 2020-04-24. It names one FDA 510(k) clearance: K043246. Product: I-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.. Reason: Activity and quantity of seeds sent in shipments were incorrect..

Recalling firm: C.R. Bard, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-12-09
Terminated: 2020-04-24
Firm location: Covington, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K043246 — BRACHYSOURCE BRACHYTHERAPY SEED IMPLANTSC.R. Bard, Inc.·cleared 2005-02-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

I-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.

Reason for recall

Activity and quantity of seeds sent in shipments were incorrect.

Data sourced from openFDA. This site is unofficial and independent of the FDA.