The Recall Desk
ModerateFDA (Devices)·Z-1453-2017·Announced 2017-03-22

LeMaitre Vascular Catheter Recalled for Missing Latex Warning Symbol

LeMaitre Vascular is recalling 46 units of Reddick Scoop Tip Cholangiogram Stiffer Catheters because the latex warning symbol was missing from 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, but the hazard is a labeling omission (missing latex symbol) rather than a direct contamination or structural defect. No illnesses or injuries are reported in the source text, fitting the criteria for a moderate severity labeling error.

Plain-English summary

LeMaitre Vascular, Inc. is recalling 46 units of the Reddick Scoop Tip Cholangiogram Stiffer Catheter with Introducer (REF# 2401-53). The recall was initiated because the Contains Latex symbol was not printed onto the box label or the sterile inner product pouch. This omission may prevent healthcare providers from identifying the latex content of the device.

The affected units are identified by Lot Number RST2413 with an expiration date of 2019-01. 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.

Healthcare facilities and distributors should stop using the affected catheters and contact LeMaitre Vascular for instructions on how to return or dispose of the products. Patients who have had these catheters used on them should consult their healthcare provider if they have a known latex allergy or experience allergic symptoms.

The recalled product

Product
LeMaitre Vascular Reddick Scoop Tip Cholangiogram Stiffer Catheter with Introducer (paper IFU) REF# 2401-53
Manufacturer
LeMaitre Vascular, Inc.
Category
Medical Device — Catheter
Hazard
Affected units
46

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot Number/Exp. Date: RST2413 2019-01

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.

See all 12 products in this recall →

Related recalls

Same manufacturer · LeMaitre Vascular, Inc.

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Same hazard · latex allergy

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