Reports received of torn corrugated breathing tubes.
TELEFLEX MEDICAL
32 recalls • • Categories: Infusion Pumps, Surgical Instruments, Other Medical Devices, Diagnostic Equipment
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.
Class I - Dangerous
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
Potential for sterile packaging to be compromised¿
Potential for sterile packaging to be compromised¿
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
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.
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.
Class I - Dangerous
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.
Class I - Dangerous
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.
Class I - Dangerous
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.
Class I - Dangerous
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.
Class I - Dangerous
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.
Class I - Dangerous
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.
Class I - Dangerous
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.
Class I - Dangerous
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.
Class I - Dangerous
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 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 tracheal and brochial swivel connectors are incorrectly labeled.
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.
Class I - Dangerous
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.
Class I - Dangerous
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.
Class I - Dangerous
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.
Class I - Dangerous
Potential for product not to be sterile.
Class I - Dangerous
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.
Reported complaints of cracks being observed, prior to use, on swivel wye adaptors of the Neonatal ConchaSmart Breathing Circuit.
Class I - Dangerous
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.
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.
Class I - Dangerous
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.
Class I - Dangerous
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.
Class I - Dangerous
The firm received reports indicating that the laser guard foil partially separated and/or slightly detached at the edges.
Class I - Dangerous
The firm received reports indicating that the laser guard foil partially separated and/or slightly detached at the edges.
Class I - Dangerous
The firm received reports indicating that the laser guard foil partially separated and/or slightly detached at the edges.
Class I - Dangerous
The firm received reports indicating that the laser guard foil partially separated and/or slightly detached at the edges.
Class I - Dangerous
The firm received reports indicating that the laser guard foil partially separated and/or slightly detached at the edges.
Class I - Dangerous
The internal tip is missing from the device, causing the device to not function as intended.
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.
Class I - Dangerous
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.
Class I - Dangerous
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.
Class I - Dangerous
The product has a non-conformity that may cause clips to mislead, jam or fall out of the applier.
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 knife handles slot depth is out of specification, so blades may not fit on the handles properly.
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.
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.
Product size listed on the labeling is incorrect.
Class I - Dangerous
Incorrect labeling; the box label indicates Pediatric, the product insert indicates an Adult device.
Class I - Dangerous
Labeling: The expiration date is not stated on the labeling, there is a potential for expired product to be used.
Class I - Dangerous
Labeling: The expiration date is not stated on the labeling, there is a potential for expired product to be used.
Class I - Dangerous
Labeling: The expiration date is not stated on the labeling, there is a potential for expired product to be used.
Class I - Dangerous
Some boxes are labeled as containing Visistat Wide devices, when they in fact they contained Visistat Regular device.
Class I - Dangerous
Some of the individual unit packaging (pouches) may be missing the lot number an expiration date.
Labeling error
Labeling inconsistency - units labeled with a 7mm tube may contain a size 6.5mm tube, and units labeled 7.5mm tube may contain a size 5.5mm tube.
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.
Class I - Dangerous
Labeling Inconsistency: The products have been labeled with the incorrect expiration date which exceeds the actual, validated 35-month shelf life.
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.
Sterility Deficiency: The packages are not sealed properly and thus the sterility is not assured.
Class I - Dangerous
The devices wings may become partially detached from the EFx Shield during use.