LeMaitre Vascular Catheter Recalled for Missing Latex Warning Label
LeMaitre Vascular is recalling Reddick Cholangiogram Stiffer Catheters because the latex warning symbol was missing from the packaging.
What this means for you
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 poses a risk of allergic reaction (anaphylaxis) to latex-sensitive patients. This fits the 'High' severity criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
LeMaitre Vascular, Inc. is recalling 179 units of the Reddick Cholangiogram Stiffer Catheter with introducer (REF# 2401-51). The recall was initiated because the 'Contains Latex' symbol was not printed on the box label or the sterile inner product pouch.
The affected lots are RST2405 (exp. 2018-12), RST2417 (exp. 2019-02), RST2425 (exp. 2019-03), and RST2449 (exp. 2019-08). These 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 providers and facilities should check their inventory for these specific lot numbers and stop using the affected catheters. Patients who have had these devices implanted should consult their healthcare provider if they have a known latex allergy or experience allergic symptoms.
The recalled product
- Product
- LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter with introducer (paper IFU) REF# 2401-51
- Manufacturer
- LeMaitre Vascular, Inc.
- Category
- Medical Device — Catheter
- Affected units
- 179
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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