The Recall Desk
HighFDA (Devices)·Z-2407-2023·Announced 2023-08-23

Centurion FMS Pak Recalled Due to Patient Injury Risk from Plastic Debris

Alcon Research recalls the Centurion FMS Pak following reports of patient injury during procedures. Plastic debris can result from over-tightening with the included plastic wrench.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II device with reported patient injury during procedures. No hospitalization or serious injury designation is specified in the source, so the score reflects a high-risk product with injury reports but insufficient detail for a higher severity level.

Plain-English summary

The Centurion FMS Pak, manufactured by Alcon Research, LTD., is being recalled due to reported patient injury during procedures. The device can generate plastic debris when over-tightened with the included plastic wrench.

Approximately 87,839 units have been distributed worldwide, including throughout the United States and numerous international markets.

Healthcare providers should contact Alcon Research for recall guidance and implement precautions to avoid over-tightening during procedures.

The recalled product

Product
Centurion FMS Pak
Manufacturer
Alcon Research, LTD.
Category
Medical Device
Hazard
Affected units
87,839

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Catalog No. 8065000133
  • 8065000134
  • 8065000138
  • 8065000139
  • 8065752192
  • 8065752193
  • 8065752200
  • 8065752201
  • 8065752202
  • 8065752203
  • 8065752216
  • 8065752217
  • 8065752245
  • 8065752917
  • 8065752918
  • 8065753134
  • 8065753135
  • 8065753136
  • 8065753159
  • Product Code 100241014

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 recalled by Alcon Research, LTD. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

Related recalls

Same manufacturer · Alcon Research, LTD.

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Same hazard · plastic debris

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