CLASS II Device recall · Reported 27 Dec 2017 · FDA Enforcement Report
I-125 CE Marked QuickLink Cartridges recalled by C.R. Bard
C.R. Bard is recalling I-125 CE Marked QuickLink Cartridges. The recall was initiated on 9 Dec 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0267-2018
- FDA event ID
- 77439
- Recalling firm
- C.R. Bard, Covington, GA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Dec 2016
- FDA classified
- 20 Dec 2017
- Reported
- 27 Dec 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 9 Dec 2016 | Recall initiated by company | |
| 20 Dec 2017 | Classified by FDA | +376 days |
| 27 Dec 2017 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Activity and quantity of seeds sent in shipments were incorrect.
Product as listed by the FDA
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.
Where it was distributed
Belgium & South Africa.
Questions about this recall
Why was it recalled?
Activity and quantity of seeds sent in shipments were incorrect.
Which lots are affected?
Product Code: 1251QCSCE, Lot No. BBAY0072, BBAY0079, BBAY0090, BBAY0071, BBAY0073.
Where was it sold?
Belgium & South Africa.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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