Medrad Avanta Multi-patient Disposable Sets. Catalog number… recallZ-0083-06 · Medrad Inc · initiated Sep 20, 2005
Terminated All recalls posted in October 2005
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medrad Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
stress crack on the stopcock
FDA root cause category: Other
What the company is doing
The recalling firm issued letters dated 9/20/05 to the hospitals and sales representative informing them of the problem and the need to return the product.
Recall details
- Recall number
- Z-0083-06
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Sep 20, 2005
- Posted by the FDA
- Oct 21, 2005
- Recalling firm
- Medrad Inc
- Quantity
- 850 units
- Product code
- LHI
- FDA submissions
- K050456
- Distribution
- The products were shipped to medical facilities in CA, CO, DE, FL, IL, MA, NC, OH, PA, and VA. The products were also shipped to sales representatives in CA, CO, FL, MA, MN, MO, OK, PA, SC, and WI. The products were sent to the recalling firm''s distributors in the Netherlands, Denmark, France, and Italy.
Product description
Medrad Avanta Multi-patient Disposable Sets. Catalog number AVA 500 MPAT
Code information (models, lots, serial numbers)
Lot numbers 50627, 50628, 51069, 51070, 51071, and 51747
Other devices under the same FDA submission
3 devices cleared under K050456 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- MEDRAD® Avanta Fluid Management Injection SystemBayer Medical Care Inc. · Injector And Syringe, Angiographic1 death5 reports
- MEDRAD® Avanta Fluid Management Injection SystemBayer Medical Care Inc. · Injector And Syringe, Angiographic1 death3 reports
- MEDRAD® Avanta Single Patient Disposable Set – Transducer Compatible AVA 500 SPAT LBayer Medical Care Inc. · Injector And Syringe, Angiographic1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 33689).
- Z-0082-06 · TerminatedMedrad Avanta Single Patient Disposable Sets. Catalog number AVA 500 SPAT
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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