Reported Aug 23, 2023 · Ongoing
Constellation Procedure Pak
Alcon Research, Ltd.
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: Alcon Research, LTD. · 714 Columbia Ave · Sinking Spring, PA · 19608-1405
Is this the product you have?
- Constellation Procedure Pak
- Lot codes and dates
Catalog No. 8065750958Product Code 100007216
- UDI-DI
380657509584Lots 14XM2J14Y1H6150HYJ150HYK151R72152CH015309X156HWN15A13R15A13T15CF2X15CF2Y15CF3015CJ4715CJ4815CWAM15CWAN15D649
- Amount recalled
- 10,580 units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
Why it was recalled
Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.
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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