LeMaitre Vascular Catheter Recalled for Missing Latex Warning Symbol
LeMaitre Vascular is recalling Reddick Scoop Tip 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 symbol, which poses a risk of allergic reaction to latex-sensitive patients. This aligns with the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
LeMaitre Vascular, Inc. is recalling 403 units of the Reddick Scoop Tip Cholangiogram Stiffer Catheter (REF# 2401-50). The recall was initiated because the Contains Latex symbol was not printed on the box label or the sterile inner product pouch.
The affected 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. Specific lot numbers and expiration dates include RST2404 (2018-01), RST2416 (2019-02), RST2424 (2019-03), RST2426 (2019-03), and RST2442 (2019-07).
Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected catheters. Patients who have had these catheters used on them should consult their healthcare provider if they have a known latex allergy or experience symptoms of a latex reaction.
The recalled product
- Product
- LeMaitre Vascular Reddick Scoop Tip Cholangiogram Stiffer Catheter (paper IFU) REF# 2401-50
- Manufacturer
- LeMaitre Vascular, Inc.
- Category
- Medical Device — Catheter
- Affected units
- 403
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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