Teleflex Medical Inc.

Due to out-of-specification, or potential out-of-specification, levels of endotoxins

Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.

There are incomplete pre-cleaning instructions within the Instructions for Use (IFU).

Teleflex LLC is initiating this voluntary field corrective action because the clip cartridges for the affected product is missing a key feature that restricts the application of the clip to the applier. With this step feature missing on the cartridge, the clip is mounted in a mor…

The product contains an expired diluent vial. If the impacted product is used, the sterility of the diluent component cannot be assured as it has passed beyond the studied shelf life of the product.

Potential for pilot balloon non-inflation or cuff non-deflation.

Specific lots have not been irradiated to eliminate pyronema and therefore the sterility of the affected products may be compromised.

Product may not be sterile

Incidents of device splitting or detaching during use

Reports received of torn corrugated breathing tubes.

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

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.

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.

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…

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 t…

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 partia…

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.

Device vented gas below the stated pressure.

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 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 b…

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.

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 r…

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.

The connector may disconnect from the tracheostomy tube during use.

Cracks may occur at the 15mm and 22mm ISO female connector.

Cracking may occur at the 15mm and 22mm ISO female connector.

Teleflex Medical has issued an advisory notification for the RUSCH Curved Reinforced Endotracheal Tube because of a discrepancy between the labeled cuff diameter and the actual cuff diameter. The actual product cuff diameter meets required specification.

Connector mount cracks which may lead to a leak failure during use and necessitate immediate replacement in the breathing circuit. If leak exists and is left untreated, patient may be deprived of adequate anesthetic gases over a period of time and serious adverse health conseque…

Customer complaints reporting that the cobb connector detached from the main connector prior to use.

The manufacturing and expiration dates are not printed on the blister pack label.