LeMaitre Vascular Cholangiogram Catheter Recalled for Missing Latex Symbol
LeMaitre Vascular is recalling Reddick 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: The recall is classified as FDA Class II, which typically corresponds to a moderate severity level. The hazard involves a labeling error regarding latex content, which is a known allergen, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
LeMaitre Vascular, Inc. is recalling 4,673 units of the Reddick Scoop Tip Cholangiogram Catheter (eIFU) REF# e2401-50. The recall was initiated because the 'Contains Latex' symbol was not printed on the box label or the sterile inner product pouch.
The affected units 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. The recall covers specific lots with expiration dates ranging from August 2018 to July 2019.
Healthcare providers and patients should check their inventory and records for these specific lot numbers. If the product is found, it should be removed from use and returned to the manufacturer or supplier according to their instructions.
The recalled product
- Product
- LeMaitre Vascular Reddick Scoop Tip Cholangiogram Catheter (eIFU) REF# e2401-50
- Manufacturer
- LeMaitre Vascular, Inc.
- Category
- Medical Device — Catheter
- Affected units
- 4,673
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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