Reported Aug 23, 2023 · Ongoing
Centurion 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?
- Centurion FMS Pak
- Lot codes and dates
Catalog No. 8065000133806500013480650001388065000139806575219280657521938065752200806575220180657522028065752203806575221680657522178065752245806575291780657529188065753134806575313580657531368065753159Product Code 100241014100241015100241019100241020100055107100055110100009955100009963100009964100009965100009960100009961100010766100056645100055945100207171100207170100208838100208338
- UDI-DI
1,339 of 1,339 codes
380650001337380650001344380650001382380650001399380657521920380657521937380657522002380657522019380657522026380657522033380657522163380657522170380657522453380657529179380657529186380657531349380657531356380657531363380657531592Lots 14WW1F14WW1H14WW1J14X6CN14X6CP14X6CR14X6CT14X6CU14X6CV14XPE914XPEA14XPEC14XPED14XPEE14XPEF14XPEH14Y8C214Y8C314Y8C414Y8C514Y8C614Y8C714YLMF14YLMH14YLMJ14YLMK14YLML14YLMM14YLMN14YLMP14YXHY14YXJ014YXJ114YXJ314YXJ414YXJ514YXJ614YXJ7150HDA150HDC150HDD
- Amount recalled
- 87,839 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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