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
- plastic-debris
- patient-injury
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.
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