Pruitt Occlusion Catheter Recalled Due to Incomplete Sterile Barrier Seals
LeMaitre Vascular is recalling Pruitt Occlusion Catheters (catalog numbers 2103-36, 2103-46, 2103-56, E2103-36, E2103-46, E2103-56) because some packages have incomplete sterile barrier seals, potentially compromising product sterility.
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 involving a sterile barrier defect on a medical device. The incomplete seals pose a risk of infection or contamination to patients, and no illnesses or injuries are reported in the source text, placing it at the upper end of High severity per the rubric.
Plain-English summary
LeMaitre Vascular, Inc. is recalling Pruitt Occlusion Catheters with catalog numbers 2103-36, 2103-46, 2103-56, E2103-36, E2103-46, and E2103-56. During internal product testing, the manufacturer discovered that some packages had incomplete seals in the sterile barrier.
The affected product has been distributed nationwide in the United States and internationally to 65 countries. The UDI-DI codes are 00840663101535 and 00840663101542. The recall affects units with lot prefixes POC, QPO, and XPO that have not yet expired.
Patients and healthcare providers who have these catheters in stock should stop using affected units immediately. Affected packages can be identified by the catalog numbers and lot prefixes listed above. Contact LeMaitre Vascular, Inc. for instructions on returning or replacing the product.
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
- 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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