Pruitt Occlusion Catheter Recall: Incomplete Sterile Barrier Seals
LeMaitre Vascular is recalling Pruitt Occlusion Catheters due to incomplete seals in the sterile barrier detected during internal testing. The defect may compromise sterility and increase infection risk.
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 recall with no reported illnesses or injuries. The incomplete sterile barrier seals represent a real risk-of-harm on an invasive medical device where sterility is critical, but injury has not yet been reported. Per the rubric, this meets the criteria for High severity.
Plain-English summary
LeMaitre Vascular, Inc. is recalling Pruitt Occlusion Catheters (catalog numbers 2103-36, 2103-46, 2103-56, E2103-36, E2103-46, E2103-56) due to incomplete seals in the sterile barrier. During internal product testing, the company identified that some packages have incomplete seals that could compromise the integrity of the sterile barrier.
Approximately 65,977 units were distributed nationwide and internationally across multiple countries. The defect poses a risk of sterility compromise, which could lead to patient infection if a compromised catheter is used during a medical procedure.
Affected products can be identified by UDI-DI numbers 00840663101535 and 00840663101542, and lot numbers with the prefixes POC, QPO, or XPO that have not yet expired. This is an FDA Class II recall. Patients and healthcare providers should contact LeMaitre Vascular for instructions on returning or managing affected products.
The recalled product
- Product
- Pruitt Occlusion Catheter. Catalog Numbers: 2103-36, 2103-46, 2103-56, E2103-36, E2103-46, E2103-56
- Manufacturer
- LeMaitre Vascular, Inc.
- Hazard
- incomplete-seal
- sterile-barrier-defect
- contamination-risk
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: 00840663101535
- 00840663101542. Catalog Numbers: 2103-36
- 2103-46
- 2103-56
- E2103-36
- E2103-46
- E2103-56. Lots not expired with the following prefix: POC
- QPO
- XPO.
Distribution
Distributed nationwide across the United States.
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