Wound dressing may have foreign matter on the product.
ConvaTec
40 recalls • • Categories: Infusion Pumps, Other Medical Devices, Surgical Instruments, Implants & Prosthetics, Diagnostic Equipment
Ostomy skin barrier package contains a pre-cut wafer of 28mm instead of 16mm and/or 35mm pre-cut wafers, as stated package labeling. If pre-cut wafers are too big the device cannot be used and if the pre-cut wafer is too small and the device user tries to apply, this could cause abrasion, stomal cut, and bleeding
Class I - Dangerous
The product does not meet sterility assurance level.
Convatec Inc is conducting a Voluntary Medical Device Recall (removal) for specific lots of the EsteemBody Soft Convex, Drainable Pouch due to inconsistency in the strength of the filter weld.
Class I - Dangerous
The kit contains a flange that has a 45mm coupling ring, however, the pouch within the kit is for a 57mm coupling ring.
Class I - Dangerous
ConvaTec are voluntarily recalling a batch of AQUACEL¿ Foam Ag Adhesive 10cm x 10cm (x 10 pack) due to the identification of visual contamination in the form of brown spots present on several dressings.
Class I - Dangerous
impaired functionality of the release liner
Class I - Dangerous
impaired functionality of the release liner
Class I - Dangerous
impaired functionality of the release liner
Class I - Dangerous
impaired functionality of the release liner
Class I - Dangerous
Firm received 10 complaints of skin barrier delamination issues (e.g. flange lifts from wafer, skin barrier layers separate) or tape border rips/tears.
Class I - Dangerous
Primary packaging labeling may be incorrect.
Class I - Dangerous
There is a potential for open seals which can compromise sterility.
ConvaTec has received complaints associated with use of convex two-piece skin barriers where the starter hole (stoma hole) is off-center on product manufactured from February 2017 to September 2018. FDA became aware of this problem via routine MDR monitoring.
An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.
An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.
An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.
An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.
Bubble Leak Testing on AbViser AutoValve IAP Monitoring Devices without Transducer confirmed the potential for a pinhole breach in the sterile barrier.
It was discovered that the stoma hole of one lots of the Esteem synergy Stomahesive Skin Barrier wafers is larger that the 7/8 inch / 22mm specified on the box label.
A portion of Lot 7H02242 outer boxes (market units) of the SUR-FIT Natura Moldable Durahesive Skin Barrier (10 pack, 45 mm, REF 411802) were incorrectly labeled as Natura Moldable Stomahesive Skin Barrier (10 pack, 45 mm, REF 411803).
Class I - Dangerous
Class I - Dangerous
Class I - Dangerous
Class I - Dangerous
Class I - Dangerous
Class I - Dangerous
Reports of tubing detaching from oxygen masks either prior to use (in packaging) or during use were made by different end users and for different batches. The failures were caused by an improper solvent bond between the oxygen tubing and the oxygen mask connector. While the defect affects less than 2% of recalled product, there is a potential for harm when oxygen supply to the user is disrupted.
Class I - Dangerous
Class I - Dangerous
Class I - Dangerous
Class I - Dangerous
Class I - Dangerous
Class I - Dangerous
Class I - Dangerous
Class I - Dangerous
Class I - Dangerous
The Nebulizer mask malfunctions in that there is reduced or no aerosol output. The malfunction occurs from the reduction in the diameter of a component part inside the nebulizer.
Convatec Inc. is recalling Flexi-seal FMS Control Kit since it does not have a 510K. In addition, an internal assessment of product performance, including a review of customer feedback, has confirmed that Flexi-Seal Control is not meeting expectations or those of customers. Specifically, the Auto-Valve feature that is unique to the Flexi-Seal Control has not been consistently performing relative
The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material.
The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material.
The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material.
The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material.
The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material.
The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material.
ConvaTec notified their customers on 6/25/2013 regarding the manufacturing irregularity that occurred related to the packaging of certain lots of Flexi-Seal Signal FMS. In certain lots, the lot number convention was duplicated on the packaging.
ConvaTec notified their customers on 6/25/2013 regarding the manufacturing irregularity that occurred related to the packaging of certain lots of Flexi-Seal Signal FMS. In certain lots, the lot number convention was duplicated on the packaging.