Reported Aug 23, 2023 · Ongoing
Infinity FMS 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?
- Infinity FMS Pak
- Lot codes and dates
Catalog No. 8065741085806575028080657502818065752086806575208780657520908065752093806575209480657520958065752096Product Code 100003158100004405100055054100009758100009094100009370100009098100009099100009100100009101
- UDI-DI
128 of 128 codes
380657410859380657502806380657502813380657520862380657520879380657520909380657520930380657520947380657520954380657520961Lots 1545321571CW1571CX15037414WCPD150374151J41151J42152H82152W361598PY1598R0159LH61571D21598RA14YLLD14YLLE150FF5150FF6151J5W1532WH153JT7155LTD1571DK1571DL1571DM1571DN1571DP1571DR1571DT1571DU15A6MW15A6MX15C33015C33115C33315C33415D42R15DH9315EL0915453915675115675215675515675614VCLK14VCLL14VCLM14XPL914XPLA
- Amount recalled
- 51,054 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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