Reported Jun 26, 2019 · Terminated
Zenith Alpha Abdominal Endovascular Graft, Reference Part Numbers: ZIMB-22-108, ZIMB-22-118, ZIMB-22-128, ZIMB-22-70,…
Cook Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cook Inc. · 750 N Daniels Way · Bloomington, IN · 47404-9120
Is this the product you have?
- Zenith Alpha Abdominal Endovascular Graft
- Reference Part Numbers
ZIMB-22-108ZIMB-22-118ZIMB-22-128ZIMB-22-70ZIMB-22-84ZIMB-22-98ZIMB-24-108ZIMB-24-118ZIMB-24-128ZIMB-24-70ZIMB-24-84ZIMB-24-98ZIMB-26-108ZIMB-26-118ZIMB-26-128ZIMB-26-70ZIMB-26-84ZIMB-26-98ZIMB-28-108ZIMB-28-118ZIMB-28-128ZIMB-28-70ZIMB-28-84ZIMB-28-98ZIMB-30-108ZIMB-30-118ZIMB-30-128ZIMB-30-70ZIMB-30-84ZIMB-30-98ZIMB-32-108ZIMB-32-118ZIMB-32-128ZIMB-32-70ZIMB-32-84ZIMB-32-98ZIMB-36-108ZIMB-36-118ZIMB-36-128ZIMB-36-70ZIMB-36-84ZIMB-36-98
- Lot codes and dates
2,009 of 2,009 codes
92217849228731923224992465299272685927283592760299276400930324593736239406776946690895065599525188955756995661609566211957538096203789620379962038296259169625917963637196405849663986 940677795224169566161957538296259189656992 955757095661629575383962591996259209656978 9221629923224792764019303246937362493940519403262940677894067799406780945329994669099466910948214794862909486313950661695224189522419952518995290479534284955544295554539555475
- Amount recalled
- 1027
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Why it was recalled
may contain a damaged gray safety lock knob, which could potentially result in difficulty or an inability to fully deploy the graft via the standard or troubleshooting method provided in the Instructions for Use (IFU). Potential adverse events that may occur if an affected product is used include a prolonged procedure and open surgical intervention.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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