The Recall Desk
ModerateFDA (Devices)·Z-0267-2018·Announced 2017-12-27

C.R. Bard Recalls I-125 QuickLink Cartridges Due to Incorrect Quantity

C.R. Bard is recalling I-125 QuickLink Cartridges because the quantity of seeds sent in shipments was incorrect.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a logistical error regarding quantity and activity, which fits the criteria for a moderate severity recall involving low-risk contamination or labeling/shipping errors without reported harm.

Plain-English summary

C.R. Bard, Inc. is recalling I-125 CE Marked QuickLink Cartridges containing Bard Brachysource Radioactive Seeds. The recall involves 134 seeds distributed to Belgium and South Africa. The specific lots affected are BBAY0072, BBAY0079, BBAY0090, BBAY0071, and BBAY0073.

The recall was initiated because the activity and quantity of seeds sent in shipments were incorrect. These medical devices are indicated for the permanent interstitial treatment of selected localized tumors, including head and neck, lung, pancreas, and early-stage prostate cancer.

Healthcare providers and distributors in the affected regions should stop using the recalled products and contact C.R. Bard for further instructions.

The recalled product

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 tr
Manufacturer
C.R. Bard, Inc.
Affected units
134

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

  • Product Code: 1251QCSCE
  • Lot No. BBAY0072
  • BBAY0079
  • BBAY0090
  • BBAY0071
  • BBAY0073.

Distribution

Distribution scope not specified by the agency.