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FDA Recalls
›Device Recalls

FDA Device Recalls

Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 941–960 of 1,000 recalls

Class IITerminated

Medtronic HY8R62R13,Custom Pack HY8R62R13 E Pack, Custom Perfusion System, Sterile, Rx.

Medtronic Perfusion Systems

Specific lots may have been manufactured with insufficient or incomplete welds.

April 29, 2021 · DeviceView details →

Class IITerminated

Probe Cover 6" x 96" regular PE w/ 3 Elastic Bands- Ultrasonic Transducer Cover Item ID: A-AU-0778NA

Exact Medical Manufacturing, Inc.

No 510k for the product to be used in a natural or surgical opening to the body

April 29, 2021 · DeviceView details →

Class IITerminated

Probe Cover - 6" x 3" x 96"-Ultrasonic Transducer Cover Item ID: SH22

Exact Medical Manufacturing, Inc.

No 510k for the product to be used in a natural or surgical opening to the body

April 29, 2021 · DeviceView details →

Class IITerminated

Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate are each intended to be used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician s prescription. Both concentrates are formulated for use in 45X proportioning systems which proportion a nominal ratio of 1 : 1.72 : 42.28 (acid : bicarbonate : water) to generate dialysate. The dialysate is intended to be pumped through a dialyzer, creating an osmotic gradient across the dialyzer membrane to exchange solutes with blood during hemodialysis.

Fresenius Medical Care Holdings, Inc.

Exposed to freezing temperatures due to refrigerated truck malfunctions

April 28, 2021 · DeviceView details →

Class IITerminated

(1) 08-4078-BB BIBAG 650 GRAMS/BAG 16 BAGS/CASE (2) 08-4080-BB BIBAG 900 grams/bag 12 bags/case For patients with acute and chronic end stage renal disease going under PD in healthcare or home setting GRANUFLO & NATURALYTE: Concentrate is formulated to be used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

Fresenius Medical Care Holdings, Inc.

Exposed to freezing temperatures due to refrigerated truck malfunctions

April 28, 2021 · DeviceView details →

Class IITerminated

The Drain Bag Set (tubings and flexible bags) is a passive, closed drainage system used as an optional receptacle during an APD treatment. The Drain Bag Set is used to collect effluent in bags rather than letting the effluent flow directly to a drain. The Drain Bag Set connects to the drain line of a cycler set to collect patient effluent by means of gravity and the pumping action of a Peritoneal Dialysis (PD) cycler. The Drain Bag Set connects to the drain line using a standard Luer lock connection. The Drain Bag Set consists of three (3) interconnected 7-liter drain bags, each with a sampling port and an occluding clamp. The tubing lines that connect each drain bag to the drain line have a snap-disconnect tubing segment. This tubing segment allows the user to disconnect individual bags by snapping the tubing apart.

Fresenius Medical Care Holdings, Inc.

Exposed to freezing temperatures due to refrigerated truck malfunctions

April 28, 2021 · DeviceView details →

Class IITerminated

Randox RX Imola Analyser with ISE, Catalog Numbers RX4900, RX4900R

Randox Laboratories Ltd.

An issue was identified where the software froze during processing of commands, which resulted in no results displayed.

April 28, 2021 · DeviceView details →

Class IITerminated

Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. For treatment of vascular aneurysms.

Medtronic Vascular, Inc.

Incorrect stentstop assembly (18fr) was used to build the delivery system component of the device. Correct stentstop assembly is 20fr.

April 28, 2021 · DeviceView details →

Class IITerminated

Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate are each intended to be used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician s prescription. Both concentrates are formulated for use in 45X proportioning systems which proportion a nominal ratio of 1 : 1.72 : 42.28 (acid : bicarbonate : water) to generate dialysate. The dialysate is intended to be pumped through a dialyzer, creating an osmotic gradient across the dialyzer membrane to exchange solutes with blood during hemodialysis.

Fresenius Medical Care Holdings, Inc.

Exposed to freezing temperatures due to refrigerated truck malfunctions

April 28, 2021 · DeviceView details →

Class IITerminated

The Fresenius APD Luer-Lock Adapter, Catalog number 050-95018, is designed to connect a peritoneal dialysis bag equipped with a luer-lock connector to a Fresenius Automated Peritoneal Dialysis (APD) cycler set that uses the Fresenius Safe-Lock¿ connector (e.g., Liberty¿ cycler, Newton IQO cycler).

Fresenius Medical Care Holdings, Inc.

Exposed to freezing temperatures due to refrigerated truck malfunctions

April 28, 2021 · DeviceView details →

Class IITerminated

026-20036A Liberty Drain Line, Luer Tap For patients with acute and chronic end stage renal disease going under PD in healthcare or home setting

Fresenius Medical Care Holdings, Inc.

Exposed to freezing temperatures due to refrigerated truck malfunctions

April 28, 2021 · DeviceView details →

Class IITerminated

NaturaLyte Dry Bicarbonate Concentrate is composed of sodium bicarbonate powder and is used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician s prescription. NaturaLyte Dry Bicarbonate Concentrate is formulated for use in 45X proportioning systems which proportion a nominal ratio of 1 : 1.72 : 42.28 (acid : bicarbonate : water) to generate dialysate. The dialysate is intended to be pumped through a dialyzer, creating an osmotic gradient across the dialyzer membrane to exchange solutes with blood during hemodialysis.

Fresenius Medical Care Holdings, Inc.

Exposed to freezing temperatures due to refrigerated truck malfunctions

April 28, 2021 · DeviceView details →

Class IITerminated

The MTS Set is a single-use, sterile (EO), non-pyrogenic, optional accessory that provides additional connections/disconnections when used with a stay"safe compatible cycler set during acute and chronic PD treatment. The MTS Set utilizes the same PIN engagement technology used in Fresenius stay"safe Patient Connectors (K041792). The MTS Set consists of two (2) stay"safe PIN Connectors at the proximal end, tubing, and a Safe-Lock connector at the distal end. The MTS Set is attached to a cycler set by a patient, care partner, or healthcare professional. The MTS Set is attached during setup to make additional connections to the cycler set when they are prescribed by a physician or when an interruption in treatment is necessary.

Fresenius Medical Care Holdings, Inc.

Exposed to freezing temperatures due to refrigerated truck malfunctions

April 28, 2021 · DeviceView details →

Class IITerminated

050-95012 Sterile Stay Safe Cap The Indications for Use/Intended Use for the Fresenius Sterile Stay Safe¿ Cap is equivalent to that for the Fresenius Stay Safe Cap and is as follows: Indications for Use Fresenius Sterile Stay Safe¿ Cap is intended to be used for closure of the stay safe peritoneal dialysis connectology system

Fresenius Medical Care Holdings, Inc.

Exposed to freezing temperatures due to refrigerated truck malfunctions

April 28, 2021 · DeviceView details →

Class IITerminated

Quanta System Sterile Optical Laser Fiber, reusable

Quanta System, S.p.A.

Product sterility is potentially compromised.

April 27, 2021 · DeviceView details →

Class IITerminated

Olympus Sterile Optical Laser Fiber, single use and reusable

Quanta System, S.p.A.

Product sterility is potentially compromised.

April 27, 2021 · DeviceView details →

Class IITerminated

Braive Growth Modulation System Break-Off Set Screws - Product Usage: intended to limit further progression of the spinal curvature and provide correction of the thoracic curve while allowing continued skeletal growth by compression of the convex side of the scoliotic curve.

Medtronic Sofamor Danek USA, Inc

Product is impacted by a thread profile defect due to a manufacturing issue.

April 27, 2021 · DeviceView details →

Class IITerminated

Quanta System Sterile Optical Laser Fiber, single use

Quanta System, S.p.A.

Product sterility is potentially compromised.

April 27, 2021 · DeviceView details →

Class IITerminated

Atec Insignia Anterior Cervical Plate System, REF 136-0354 Insignia, ACP, 3-Level, 54 mm, Rx Only, Non-Sterile, UDI: (01)00190376268583

Alphatec Spine, Inc.

There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively.

April 26, 2021 · DeviceView details →

Class IITerminated

Atec Insignia Anterior Cervical Plate System, REF 136-0248 Insignia, ACP, 2-Level, 48 mm, Rx Only, Non-Sterile, UDI: (01)00190376268521

Alphatec Spine, Inc.

There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively.

April 26, 2021 · DeviceView details →

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