LeMaitre Vascular Cholangiogram Catheter Recalled for Missing Latex Labeling
LeMaitre Vascular is recalling 2,065 units of Scoop Tip Cholangiogram Catheters because the latex symbol was not printed on 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 3/5 (High).
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: The recall involves a medical device with a missing latex warning symbol, which poses a risk of allergic reaction to latex-sensitive patients. This aligns with the rubric for high-risk products where injury has not yet been reported.
Plain-English summary
LeMaitre Vascular, Inc. is recalling 2,065 units of the LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (eIFU), REF# e2401-53. The recall was initiated because the Contains Latex symbol was not printed onto the box label or the sterile inner product pouch.
The affected lots are RST2392 (Exp. 2018-09), RST2400 (Exp. 2018-10), RST2408 (Exp. 2018-12), RST2419 (Exp. 2019-04), RST2431 (Exp. 2019-04), RST2436 (Exp. 2019-05), and RST2447 (Exp. 2019-08). The products were distributed worldwide, including in the United States, Austria, Belgium, France, Germany, Italy, Luxembourg, Morocco, Saudi Arabia, Singapore, Spain, Switzerland, the UAE, and the UK.
Healthcare providers and facilities should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be removed from use and returned to the manufacturer or distributor according to their instructions. Patients who have received this device should consult their healthcare provider if they have a known latex allergy.
The recalled product
- Product
- LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF# e2401-53
- Manufacturer
- LeMaitre Vascular, Inc.
- Category
- Medical Device — Catheter
- Affected units
- 2,065
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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