LeMaitre Vascular Cholangiogram Catheter Recalled for Missing Latex Labeling
LeMaitre Vascular is recalling Reddick Cholangiogram Catheters because the latex symbol was not printed on the packaging, posing a risk to latex-allergic patients.
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, which is a high-risk allergen. Per the rubric, allergen mislabeling on common allergens is classified as High severity, even if no injuries are reported.
Plain-English summary
LeMaitre Vascular, Inc. is recalling 5,601 units of the Reddick Cholangiogram Catheter (eIFU) REF# e2400-50. The recall was initiated because the Contains Latex symbol was not printed onto the box label or the sterile inner product pouch. This labeling omission creates a risk for patients or healthcare providers with latex allergies who may be exposed to the device without prior warning.
The affected lots were distributed worldwide, including in the United States and various countries in Europe, the Middle East, and Asia. The specific lot numbers and expiration dates range from RED1743 (exp. 2018-09) to RED1775 (exp. 2019-07). Healthcare facilities and distributors should check their inventory for these specific lot numbers.
Patients and healthcare providers should contact LeMaitre Vascular for further information or to arrange for the return of the affected devices. Individuals with known latex allergies should avoid using these specific lots until the labeling issue is resolved or the devices are replaced.
The recalled product
- Product
- LeMaitre Vascular Reddick Cholangiogram Catheter (eIFU) REF# e2400-50
- Manufacturer
- LeMaitre Vascular, Inc.
- Category
- Medical Device — Catheter
- Affected units
- 5,601
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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