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QuickLink™
Bard Brachytherapy, Inc. · Model 70310SGA5 · UDI-DI 00801741079290
IWJ
Prescription
10
510(k) clearances
164
Adverse events
11
Recalls
46
Facilities
Description
QuickLink™ Relay System Components QuickLink™ Relay Rack
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-02-22 | Sirtex Medical Limited | There is a potential presence of particulate matter in the D-Vial. |
| 2019-02-08 | Riverpoint Medical, LLC | The integrity of the sterile grid packaging is potentially compromised. |
| 2018-10-09 | Theragenics Corporation | Some of the pouches containing Brachytherapy Applicator Needles (18g x 20cm) were not sealed |
| 2018-01-09 | Riverpoint Medical, LLC | Product is labeled with "CE", but is not yet approved in the European Union. |
| 2011-08-12 | Worldwide Medical Technologies, LLC | Length of the cannula hub is longer and may not permit a fit with the Applicator |
| 2009-09-01 | Medical Device Technologies, Inc. | Medical Device Technologies doing business as Angiotech has conducted a recall on Angiotech Breast Localization Needles, Soft Tissue Biopsy Needles, Vascular Access Needles, Bone B |
| 2007-11-15 | Alpha Omega Services Inc | There is a possibility that the Flexiguide Needle tip is defective. There is the potential for the needles tip to leak, thereby breaking the sterile boundary and possibly contamin |
| 2007-11-15 | Alpha Omega Services Inc | There is a possibility that the Flexiguide Needle tip is defective. There is the potential for the needles tip to leak, thereby breaking the sterile boundary and possibly contamin |
| 2007-11-15 | Alpha Omega Services Inc | There is a possibility that the Flexiguide Needle tip is defective. There is the potential for the needles tip to leak, thereby breaking the sterile boundary and possibly contamin |
| 2007-11-15 | Alpha Omega Services Inc | There is a possibility that the Flexiguide Needle tip is defective. There is the potential for the needles tip to leak, thereby breaking the sterile boundary and possibly contamin |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.