LeMaitre Vascular Reddick Cholangiogram Catheter Recalled for Missing Latex Labeling
LeMaitre Vascular is recalling 340 Reddick Cholangiogram Stiffer Catheters because the latex 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 and involves a labeling error (missing latex symbol) without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
LeMaitre Vascular, Inc. is recalling 340 units of the Reddick Cholangiogram Stiffer Catheter (eIFU) REF# e2400-51. 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 are RED1752 (expiration 2018-12), RED1758 (expiration 2019-01), and RED1772 (expiration 2019-06). 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.
This is a Class II recall. Patients with known latex allergies should consult their healthcare providers regarding the use of these devices. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter (eIFU) REF# e2400-51
- Manufacturer
- LeMaitre Vascular, Inc.
- Category
- Medical Device — Catheter
- Affected units
- 340
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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