Category
Medical device recalls
39229 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2017-08-16FDA-DeviceValorem Surgical LLCClass IIPALLAS M/MAXIMIS 5.5 mm Instrument Tap. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
Devices are not consistent with Quality System Requirements.
- 2017-08-16FDA-DeviceC.R. Bard, Inc.Class IIBARD DISPOZ-A-BAG Leg Bag with Flip-Flo Valve with Drain Extension, Extension Tube and Latex Straps, 19 oz. Packaged as single unit in thermoformed trays. There are 50 units per case. Product Usage: Vinyl leg bag to be used with male external catheters, Foley catheters, or moth other types of urinary catheters, which are intended for use for bladder management including urine drainage, collection and measurement.
Customer complaint of a cut in the side of the leg bag, indicating a potential breach of the product's sterile barrier.
- 2017-08-16FDA-DeviceSorin Group USA, Inc.Class IISorin Group Aortic Arch Cannula, 7 mm x 10 in x 3/8 in, Rx Only, Sterile Product Usage: The Aortic Arch Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
Identification of excess plastic on the tip of the cannula.
- 2017-08-16FDA-DeviceInternational Medsurg Connection, Inc.Class IIPiston Syringe, 60 CC L/S, 50 per box, 8 boxes/case, 400/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.
Insufficient documentation to support product sterility claims.
- 2017-08-16FDA-DeviceInternational Medsurg Connection, Inc.Class IIPiston Syringe, 60 CC L/L, 50 per box, 8 boxes/case, 400/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.
Insufficient documentation to support product sterility claims.
- 2017-08-16FDA-DeviceInternational Medsurg Connection, Inc.Class IIPiston Syringe, 30 CC L/S, 50 per box, 9 boxes/case, 450/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.
Insufficient documentation to support product sterility claims.
- 2017-08-16FDA-DeviceInternational Medsurg Connection, Inc.Class IIPiston Syringe, 30 CC L/L, 50 per box, 9 boxes/case, 450/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.
Insufficient documentation to support product sterility claims.
- 2017-08-16FDA-DeviceInternational Medsurg Connection, Inc.Class IIPiston Syringe, 20 CC L/S, 100 per box, 9 boxes/case, 900/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.
Insufficient documentation to support product sterility claims.
- 2017-08-16FDA-DeviceInternational Medsurg Connection, Inc.Class IIPiston Syringe, 20 CC L/L, 100 per box, 9 boxes/case, 900/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.
Insufficient documentation to support product sterility claims.
- 2017-08-16FDA-DeviceInternational Medsurg Connection, Inc.Class IIPiston Syringe, 10 CC L/S, 100 per box, 12 boxes/case, 1,200/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.
Insufficient documentation to support product sterility claims.
- 2017-08-16FDA-DeviceInternational Medsurg Connection, Inc.Class IIPiston Syringe, 10 CC L/L, 100 per box, 12 boxes/case, 1,200/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.
Insufficient documentation to support product sterility claims.
- 2017-08-16FDA-DeviceInternational Medsurg Connection, Inc.Class IIPiston Syringe, 5 CC L/S, 100 per box, 20 boxes/case, 2,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.
Insufficient documentation to support product sterility claims.
- 2017-08-16FDA-DeviceInternational Medsurg Connection, Inc.Class IIPiston Syringe, 5 CC L/L, 100 per box, 20 boxes/case, 2,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.
Insufficient documentation to support product sterility claims.
- 2017-08-16FDA-DeviceInternational Medsurg Connection, Inc.Class IIPiston Syringe, 3 CC L/S, 100 per box, 30 boxes/case, 3,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.
Insufficient documentation to support product sterility claims.
- 2017-08-16FDA-DeviceInternational Medsurg Connection, Inc.Class IIPiston Syringe, 3 CC L/L, 100 per box, 30 boxes/case, 3,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.
Insufficient documentation to support product sterility claims.
- 2017-08-16FDA-DeviceInternational Medsurg Connection, Inc.Class IIPiston Syringe, 1 CC L/S, 100 per box, 40 boxes/case, 4,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.
Insufficient documentation to support product sterility claims.
- 2017-08-16FDA-DeviceInternational Medsurg Connection, Inc.Class IIPiston Syringe and Hypodermic Needle, 10 CC L/L 22 G X 1.5, 100 per box, 10 boxes/case, 1,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.
Insufficient documentation to support product sterility claims.
- 2017-08-16FDA-DeviceInternational Medsurg Connection, Inc.Class IIPiston Syringe and Hypodermic Needle, 10 CC L/L 22 G X 1.0, 100 per box, 10 boxes/case, 1,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.
Insufficient documentation to support product sterility claims.
- 2017-08-16FDA-DeviceInternational Medsurg Connection, Inc.Class IIPiston Syringe and Hypodermic Needle, 10 CC L/L 21 G X 1.5, 100 per box, 10 boxes/case, 1,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.
Insufficient documentation to support product sterility claims.
- 2017-08-16FDA-DeviceInternational Medsurg Connection, Inc.Class IIPiston Syringe and Hypodermic Needle, 10 CC L/L 21 G X 1.0, 100 per box, 10 boxes/case, 1,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.
Insufficient documentation to support product sterility claims.
- 2017-08-16FDA-DeviceInternational Medsurg Connection, Inc.Class IIPiston Syringe and Hypodermic Needle, 10 CC L/L 20 G X 1.5, 100 per box, 10 boxes/case, 1,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.
Insufficient documentation to support product sterility claims.
- 2017-08-16FDA-DeviceInternational Medsurg Connection, Inc.Class IIPiston Syringe and Hypodermic Needle, 10 CC L/L 20 G X 1.0, 100 per box, 10 boxes/case, 1,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.
Insufficient documentation to support product sterility claims.
- 2017-08-16FDA-DeviceInternational Medsurg Connection, Inc.Class IIPiston Syringe and Hypodermic Needle, 5 CC L/L 22 G X 1.5, 100 per box, 15 boxes/case, 1,500/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.
Insufficient documentation to support product sterility claims.
- 2017-08-16FDA-DeviceInternational Medsurg Connection, Inc.Class IIPiston Syringe and Hypodermic Needle, 5 CC L/L 22 G X 1.0, 100 per box, 15 boxes/case, 1,500/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.
Insufficient documentation to support product sterility claims.
- 2017-08-16FDA-DeviceInternational Medsurg Connection, Inc.Class IIPiston Syringe and Hypodermic Needle, 5 CC L/L 21 G X 1.5, 100 per box, 15 boxes/case, 1,500/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.
Insufficient documentation to support product sterility claims.
- 2017-08-16FDA-DeviceInternational Medsurg Connection, Inc.Class IIPiston Syringe and Hypodermic Needle, 5 CC L/L 21 G X 1.0, 100 per box, 15 boxes/case, 1,500/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.
Insufficient documentation to support product sterility claims.
- 2017-08-16FDA-DeviceInternational Medsurg Connection, Inc.Class IIPiston Syringe and Hypodermic Needle, 5 CC L/L 20 G X 1.5, 100 per box, 15 boxes/case, 1,500/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.
Insufficient documentation to support product sterility claims.
- 2017-08-16FDA-DeviceInternational Medsurg Connection, Inc.Class IIPiston Syringe and Hypodermic Needle, 5 CC L/L 20 G X 1.0, 100 per box, 15 boxes/case, 1,500/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.
Insufficient documentation to support product sterility claims.
- 2017-08-16FDA-DeviceInternational Medsurg Connection, Inc.Class IIPiston Syringe and Hypodermic Needle, 3 CC L/L 25 G X 5/8, 100 per box, 24 boxes/case, 2,400/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.
Insufficient documentation to support product sterility claims.
- 2017-08-16FDA-DeviceInternational Medsurg Connection, Inc.Class IIPiston Syringe and Hypodermic Needle, 3 CC L/L 25 G X 1.0, 100 per box, 24 boxes/case, 2,400/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.
Insufficient documentation to support product sterility claims.
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