OrthoPediatrics Corp.is voluntarily recalling multiple lots of the 3.5mm Bowed Locking Compression Femur 14-hole Plate and 18-hole Plate due to the devices being mislabeled.
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Surgical Instruments
🏥 Medical Devices • 6,839 recalls
OrthoPediatrics Corp.is voluntarily recalling multiple lots of the 3.5mm Bowed Locking Compression Femur 14-hole Plate and 18-hole Plate due to the devices being mislabeled.
Class I - Dangerous
The recalling firm identified ten devices which were distributed and could potentially be non-compliant. These devices potentially underwent a routine manufacturing test with non-compliant parameters, which may result in a small blister in the epoxy over transducers in the treatment zone. It is not known at the time the recall was initiated whether the non-compliant test parameters, or presence of the blisters, adversely affect operation of the device.
Class I - Dangerous
During an FDA inspection it was found out that the Practical Foley Catheters to be potentially nonsterile.
Cather, Ultrasound, Intravascular The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters.
Arrow International
Class I - Dangerous
Notification of component molding abnormality by supplier used to package certain Arrow Select Kit (ASK) products.
Catheter, Intravascular, Therapeutic, Long Term Greater than 30 days. An access kit only, contains no base components
Arrow International
Class I - Dangerous
Notification of component molding abnormality by supplier used to package certain Arrow Select Kit (ASK) products.
Catheter, Percutaneous The Arrow Single-Lumen Catheter permits venous access to the central circulation.
Arrow International
Class I - Dangerous
Notification of component molding abnormality by supplier used to package certain Arrow Select Kit (ASK) products.
Biosense Webster, Inc. is initiating a voluntary correction to re-install identified CARTO 3 Systems that were moved and installed in China without testing and approval by Biosense Webster Technical Services, as described in the Instructions for Use (IFU).
Class I - Dangerous
During an FDA inspection it was found out that the Practical Foley Catheters to be potentially nonsterile.
Class I - Dangerous
Notification of component molding abnormality by supplier used to package certain Arrow Select Kit (ASK) products.
Tip Breakage at the glue joint between the obturator body and tip
Class I - Dangerous
Nylon Surgical Sutures are recalled because the seals may become open during distribution or subsequent packaging.
Class I - Dangerous
Post Market Surveillance cases reported to Maquet showing instances in which the welded joint between the square mount and the first fixable swivel joint of Maquet's Connecting Bracket (Fixture) Device is broken.
Class I - Dangerous
Shipping carton labeling error.
Arterial Line Catheterization Kit with Sharps Safety Features Permits access to the peripheral arterial circulation or to other small vessels.
Arrow International
Class I - Dangerous
Shipping carton labeling error.
Class I - Dangerous
Polypropylene Surgical Sutures are recalled because the seals may become open during distribution or subsequent packaging.
Class I - Dangerous
After receiving a complaint the firm disclosed that Conventional Stainless Steel Surgical Blade catalog number 371712 lot 0088464 was incorrectly identified in the single unit foil pack as 12 instead of 12B.
Field failures were reported related to the da Vinci Xi Surgical System EndoWrist Stapler 45 and 30 instruments having an interruption in shaft rotation and / or instrument jaws not opening.
Geo-Med, TURP/CYSTO PACK PGYBK REF 89-7931.07, Rx Only, STERILE EO, Custom surgical kit.
DeRoyal Industries
Class I - Dangerous
The firm is recalling two custom surgical kits containing the BARD(TM) Toomey Irrigation Syringe 70cc with Resectoscope Tip, Catheter Tip, Luer Adapter and Cap. The BARD(TM) component is being recalled for a possible slit defect on the package that may affect the component's sterility.
Field failures were reported related to the da Vinci Xi Surgical System EndoWrist Stapler 45 and 30 instruments having an interruption in shaft rotation and / or instrument jaws not opening.