Teleflex Medical

Reports received of torn corrugated breathing tubes.

Reports received of torn corrugated breathing tubes.

The firm received reports indicating PTD tip separation during use.

The firm received reports indicating PTD tip separation during use.

The firm received reports indicating PTD tip separation during use.

The firm received reports indicating PTD tip separation during use.

The firm received reports indicating PTD tip separation during use.

The firm received reports indicating PTD tip separation during use.

The firm received reports indicating PTD tip separation during use.

Teleflex is voluntarily recalling the products referenced above due to customers reporting that the laryngoscope handles develop cracks and/or break at the hinge.

Teleflex is recalling this product due to a lack of assurance of sterility.

Potential sterility issue

Breaking at the point of a welded joint

Breaking at the point of a welded joint

Breaking at the point of a welded joint

Breaking at the point of a welded joint

Breaking at the point of a welded joint

Breaking at the point of a welded joint

Breaking at the point of a welded joint

Potential for sterile packaging to be compromised

Potential for sterile packaging to be compromised

Teleflex is initiating a voluntary recall for the above-mentioned products due to reports indicating that the laser guard foil partially separated and/or slightly detached at the edges in the presence of moisture.

There is a potential for the device packaging to become compromised; thus, the sterility of the device cannot be guaranteed.

There is a potential for the device packaging to become compromised; thus, the sterility of the device cannot be guaranteed.

The products are being recalled due to reports of breakage broke at the point of a welded joint either prior to use during setup or during use inside the patient's mouth.

The products are being recalled due to reports of breakage broke at the point of a welded joint either prior to use during setup or during use inside the patient's mouth.

There is the potential for water to flood the column and enter the circuit under circumstances where an abnormal pressure differential is created between the water bottle and the column during high flow oxygen therapy.

There is the potential for water to flood the column and enter the circuit under circumstances where an abnormal pressure differential is created between the water bottle and the column during high flow oxygen therapy.

There is the potential for water to flood the column and enter the circuit under circumstances where an abnormal pressure differential is created between the water bottle and the column during high flow oxygen therapy.

There is the potential for water to flood the column and enter the circuit under circumstances where an abnormal pressure differential is created between the water bottle and the column during high flow oxygen therapy.

The tracheal and brochial swivel connectors are incorrectly labeled.

Teleflex received the attached Medical Device Recall Notice from Pajunk Medical. Teleflex Medical is a distributor of Pajunk products. According to the notice, Pajunk internally identified a packaging problem that may affect certain batches of the SPROTTE lumbar puncture cannulas with introducer. Due to this problem Pajunk cannot guarantee the sterility of the affected batches.

Teleflex received the attached Medical Device Recall Notice from Pajunk Medical. Teleflex Medical is a distributor of Pajunk products. According to the notice, Pajunk internally identified a packaging problem that may affect certain batches of the SPROTTE lumbar puncture cannulas with introducer. Due to this problem Pajunk cannot guarantee the sterility of the affected batches.

The safety cap attached to needles within the needle sets may become dislodged exposing the needle and potentially causing the needle to protrude through the packaging. If this issue is not detected, the immediate risk of exposure to the affected devices is needle stick injury to the clinician or health care professional. In addition, a puncture of the packaging may compromise the sterility of the needle.

The safety cap attached to needles within the needle sets may become dislodged exposing the needle and potentially causing the needle to protrude through the packaging. If this issue is not detected, the immediate risk of exposure to the affected devices is needle stick injury to the clinician or health care professional. In addition, a puncture of the packaging may compromise the sterility of the needle.

The safety cap attached to needles within the needle sets may become dislodged exposing the needle and potentially causing the needle to protrude through the packaging. If this issue is not detected, the immediate risk of exposure to the affected devices is needle stick injury to the clinician or health care professional. In addition, a puncture of the packaging may compromise the sterility of the needle.

Certain clip appliers have an increase in misloading and/or jamming related complaints that may be due to a discrepancy in the specification a component. Misloading and/or jamming may lead to clips falling out of the applier, clip breakage, or the jaws becoming locked in a partially closed position (jammed).

Certain clip appliers have an increase in misloading and/or jamming related complaints that may be due to a discrepancy in the specification a component. Misloading and/or jamming may lead to clips falling out of the applier, clip breakage, or the jaws becoming locked in a partially closed position (jammed).

Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT). Disconnection from the breathing circuit may result in insufficient oxygenation, requiring medical intervention.

Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT). Disconnection from the breathing circuit may result in insufficient oxygenation, requiring medical intervention.

Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT). Disconnection from the breathing circuit may result in insufficient oxygenation, requiring medical intervention.

Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT). Disconnection from the breathing circuit may result in insufficient oxygenation, requiring medical intervention.

Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT). Disconnection from the breathing circuit may result in insufficient oxygenation, requiring medical intervention.

Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT). Disconnection from the breathing circuit may result in insufficient oxygenation, requiring medical intervention.

Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT). Disconnection from the breathing circuit may result in insufficient oxygenation, requiring medical intervention.

Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT). Disconnection from the breathing circuit may result in insufficient oxygenation, requiring medical intervention.

Potential for product not to be sterile.

This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) indicating that there is an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the Endotracheal tube.

This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) indicating that there is an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the Endotracheal tube.

This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) indicating that there is an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the Endotracheal tube.

This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) indicating that there is an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the Endotracheal tube.

This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) indicating that there is an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the Endotracheal tube.

This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) indicating that there is an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the Endotracheal tube.

This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) indicating that there is an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the Endotracheal tube.

This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) indicating that there is an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the Endotracheal tube.

Reported complaints of cracks being observed, prior to use, on swivel wye adaptors of the Neonatal ConchaSmart Breathing Circuit.

The firm received reports indicating that the laser guard foil partially separated and/or slightly detached at the edges.

The firm received reports indicating that the laser guard foil partially separated and/or slightly detached at the edges.

The firm received reports indicating that the laser guard foil partially separated and/or slightly detached at the edges.

The firm received reports indicating that the laser guard foil partially separated and/or slightly detached at the edges.

The firm received reports indicating that the laser guard foil partially separated and/or slightly detached at the edges.

The device label incorrectly states that the device is sterile. This product is an externally applied male condom-type catheter designed for the management of male incontinence as an alternative to incontinence pads. In normal use, the device is neither expected nor required to be sterile.

The device label incorrectly states that the device is sterile. This product is an externally applied male condom-type catheter designed for the management of male incontinence as an alternative to incontinence pads. In normal use, the device is neither expected nor required to be sterile.

The device labels are not UDI compliant. The missing UDI compliance information on the labelling would not affect the function/performance of the device itself. Other label information and warnings are unaffected by this labelling.

The device labels are not UDI compliant. The missing UDI compliance information on the labelling is not likely to affect the function/performance of the device itself. Other label information and warnings are unaffected by this labelling.

The internal tip is missing from the device, causing the device to not function as intended.

Some boxes are labeled as Visistat Wide devices, when in fact the contain Visistat Regular devices. The 6 individually packaged units within the boxes are correctly labeled.

There is potential for a piece of the distal tip on the Percuvance shaft to become deformed and possibly break off during use. If a piece did break off it could compromise the functionality and security of the tool tip. Should this occur during use, surgical intervention may be required.

There is potential for a piece of the distal tip on the Percuvance shaft to become deformed and possibly break off during use. If a piece did break off it could compromise the functionality and security of the tool tip. Should this occur during use, surgical intervention may be required.

Teleflex is recalling these products because the jaws of the tool tip may break, causing a fragment of the tool tip to fall off during use.

The product has a non-conformity that may cause clips to mislead, jam or fall out of the applier.

For some of the recalled products, the security of the connection between the shaft and the tool tip may be compromised. For certain other recalled lots of the products, the jaws of the tool tips may close abruptly.

For some of the recalled products, the security of the connection between the shaft and the tool tip may be compromised. For certain other recalled lots of the products, the jaws of the tool tips may close abruptly.

For some of the recalled products, the security of the connection between the shaft and the tool tip may be compromised. For certain other recalled lots of the products, the jaws of the tool tips may close abruptly.

For some of the recalled products, the security of the connection between the shaft and the tool tip may be compromised. For certain other recalled lots of the products, the jaws of the tool tips may close abruptly.

For some of the recalled products, the security of the connection between the shaft and the tool tip may be compromised. For certain other recalled lots of the products, the jaws of the tool tips may close abruptly.

For some of the recalled products, the security of the connection between the shaft and the tool tip may be compromised. For certain other recalled lots of the products, the jaws of the tool tips may close abruptly.

Teleflex Medical is recalling the affected product because there may be missing or incomplete information on the package label.

Product size listed on the labeling is incorrect.

Incorrect labeling; the box label indicates Pediatric, the product insert indicates an Adult device.

Labeling: The expiration date is not stated on the labeling, there is a potential for expired product to be used.

Labeling: The expiration date is not stated on the labeling, there is a potential for expired product to be used.

Labeling: The expiration date is not stated on the labeling, there is a potential for expired product to be used.

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Some of the individual unit packaging (pouches) may be missing the lot number an expiration date.

Some boxes are labeled as containing Visistat Wide devices, when they in fact they contained Visistat Regular device.

Labeling error

The pouch may contain the incorrect Rusch Green Lite product size. Pouches that are labeled as containing RUSCH GREEN LITE MAC 1 may instead contain RUSCH GREEN LITE MAC 2.

Labeling Inconsistency: The products have been labeled with the incorrect expiration date which exceeds the actual, validated 35-month shelf life.

Sterility Deficiency: The packages are not sealed properly and thus the sterility is not assured.

The devices wings may become partially detached from the EFx Shield during use.

Sterility: Due to a potential incomplete seal on the outer sterile package.

Sterility: Due to a potential incomplete seal on the outer sterile package.

Sterility: Due to a potential incomplete seal on the outer sterile package.

Sterility: Due to a potential incomplete seal on the outer sterile package.

Sterility: Due to a potential incomplete seal on the outer sterile package.

Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.

Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.

Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.

Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.