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. 8065000133
    • 8065000134
    • 8065000138
    • 8065000139
    • 8065752192
    • 8065752193
    • 8065752200
    • 8065752201
    • 8065752202
    • 8065752203
    • 8065752216
    • 8065752217
    • 8065752245
    • 8065752917
    • 8065752918
    • 8065753134
    • 8065753135
    • 8065753136
    • 8065753159
    • Product Code 100241014
    • 100241015
    • 100241019
    • 100241020
    • 100055107
    • 100055110
    • 100009955
    • 100009963
    • 100009964
    • 100009965
    • 100009960
    • 100009961
    • 100010766
    • 100056645
    • 100055945
    • 100207171
    • 100207170
    • 100208838
    • 100208338
  • UDI-DI

    1,339 of 1,339 codes

    • 380650001337
    • 380650001344
    • 380650001382
    • 380650001399
    • 380657521920
    • 380657521937
    • 380657522002
    • 380657522019
    • 380657522026
    • 380657522033
    • 380657522163
    • 380657522170
    • 380657522453
    • 380657529179
    • 380657529186
    • 380657531349
    • 380657531356
    • 380657531363
    • 380657531592
    • Lots 14WW1F
    • 14WW1H
    • 14WW1J
    • 14X6CN
    • 14X6CP
    • 14X6CR
    • 14X6CT
    • 14X6CU
    • 14X6CV
    • 14XPE9
    • 14XPEA
    • 14XPEC
    • 14XPED
    • 14XPEE
    • 14XPEF
    • 14XPEH
    • 14Y8C2
    • 14Y8C3
    • 14Y8C4
    • 14Y8C5
    • 14Y8C6
    • 14Y8C7
    • 14YLMF
    • 14YLMH
    • 14YLMJ
    • 14YLMK
    • 14YLML
    • 14YLMM
    • 14YLMN
    • 14YLMP
    • 14YXHY
    • 14YXJ0
    • 14YXJ1
    • 14YXJ3
    • 14YXJ4
    • 14YXJ5
    • 14YXJ6
    • 14YXJ7
    • 150HDA
    • 150HDC
    • 150HDD
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.

Want the full recall guide?

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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:37 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.