LeMaitre Vascular Cholangiogram Catheter Recalled for Missing Latex Symbol
LeMaitre Vascular is recalling 247 units of Scoop Tip Cholangiogram Catheters because the latex warning symbol was missing from the packaging.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a labeling error (missing latex symbol) which falls under the 'Minor labeling errors' criterion for a Moderate severity score.
Plain-English summary
LeMaitre Vascular, Inc. is recalling 247 units of the LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (paper IFU), REF# 2401-52. The recall is due to a labeling defect where the Contains Latex symbol was not printed on the box label or the sterile inner product pouch.
The affected lots are RST2394 (exp. 2018-09), RST2411 (exp. 2019-01), RST2412 (exp. 2019-01), and RST2459 (exp. 2019-10). The products were distributed worldwide, including the US, Austria, Belgium, France, Germany, Italy, Luxembourg, Morocco, Saudi Arabia, Singapore, Spain, Switzerland, UAE, and UK.
Healthcare facilities should stop using these specific lots and contact the manufacturer for instructions. Patients with latex allergies should consult their healthcare provider if they have used these devices.
The recalled product
- Product
- LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (paper IFU) REF# 2401-52
- Manufacturer
- LeMaitre Vascular, Inc.
- Category
- Medical Device — Catheter
- Affected units
- 247
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 recalled by LeMaitre Vascular, Inc. 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.
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