LeMaitre Vascular Cholangiogram Catheter Recalled for Missing Latex Symbol
LeMaitre Vascular is recalling Reddick 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 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 Class II recall involving a labeling error (missing latex symbol) which poses a risk to patients with latex allergies, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
LeMaitre Vascular, Inc. is recalling 2,065 units of the Reddick Scoop Tip Cholangiogram Catheter with Introducer (REF# e2401-51). 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 include RST2403, RST2409, RST2410, RST2427, RST2434, RST2439, and RST2444, with expiration dates ranging from December 2018 to July 2019. 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 facilities and distributors should stop using the affected products and contact LeMaitre Vascular for instructions on return or replacement. Patients who have already received the product should consult their healthcare provider if they have a known latex allergy.
The recalled product
- Product
- LeMaitre Vascular Reddick Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF# e2401-51
- 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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