LeMaitre Vascular Scoop Tip Cholangiogram Catheter Recalled for Missing Latex Symbol
LeMaitre Vascular is recalling 4,673 units of Scoop Tip Cholangiogram Catheters because the latex warning symbol was not printed on the packaging.
What this means for you
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 score. The hazard is a labeling error (missing latex symbol) which poses a risk to latex-allergic individuals, but no injuries or illnesses are reported in the source text.
Plain-English summary
LeMaitre Vascular, Inc. is recalling 4,673 units of the LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (eIFU), reference number e2401-52. 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 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. Specific lot numbers and expiration dates range from September 2018 to August 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 distributor according to their instructions.
The recalled product
- Product
- LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF# e2401-52
- 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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