Pruitt Irrigation Occlusion Catheter Recalled for Incomplete Sterile Seals
LeMaitre Vascular is recalling Pruitt Irrigation Occlusion Catheters (Catalog Numbers 2102-09, E2102-09) due to incomplete sterile barrier seals found during internal testing. The defect affects approximately 26,872 units distributed nationwide and internationally.
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: This is an FDA Class II recall of a medical device with a sterile barrier defect that could compromise product sterility and pose a risk of infection or other harm. The source text does not report any illnesses or injuries, making this a risk-of-harm situation where injury has not yet been reported, which places it at score 3 per the rubric.
Plain-English summary
LeMaitre Vascular, Inc. is recalling the Pruitt Irrigation Occlusion Catheter (Catalog Numbers 2102-09, E2102-09) due to incomplete seals in the sterile barrier packaging. During internal product testing, the company observed that some packages had incomplete seals that could compromise the sterility of the product.
Approximately 26,872 units have been distributed nationwide and internationally to 70 countries including Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, France, Germany, India, Italy, Japan, Mexico, Netherlands, Poland, Singapore, South Africa, South Korea, Spain, Switzerland, United Kingdom, and others.
The affected devices have Catalog Numbers 2102-09 or E2102-09, with UDI-DI codes 00840663101580, 00840663101559, 00840663101566, 00840663101597, 00840663101573, or 00840663101603, and lot numbers with the prefixes PIO, QPI, or XPI that have not expired.
Patients and healthcare providers who have this product should contact LeMaitre Vascular, Inc. for further instructions regarding return or replacement options.
The recalled product
- Product
- Pruitt Irrigation Occlusion Catheter. Catalog Numbers: 2102-09, E2102-09.
- Manufacturer
- LeMaitre Vascular, Inc.
- Hazard
- sterile-barrier-defect
- incomplete-seal
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 (9)
- UDI-DI: 00840663101580
- 00840663101559
- 00840663101566
- 00840663101597
- 00840663101573
- 00840663101603. Catalog Numbers: 2102-09
- E2102-09. Lot not expired with the following prefix: PIO
- QPI
- XPI.
Distribution
Distributed nationwide across the United States.
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