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Surgical Instruments

🏥 Medical Devices • 6,839 recalls

BD SafetyGlide" Injection Needle Catalog #305917 The SafetyGlide " needle is intended to be used for general purpose injection, aspiration of fluids from parts of the body below the surface of the skin, injection into intravenous ports and tubings external to the patient. The needlestick prevention feature of the device contains a mechanism that covers the needlepoint after use. In the activated position the needle cover guards against accidental needle sticks during normal handling and disposal of the used needle/syringe combination

Becton Dickinson & Company

Class I - Dangerous

BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required.

Sep 16, 2016 Surgical Instruments Nationwide View Details →

10" Smallbore Ext Set w/6-Port NanoClave¿ Manifold (Orange, Red, Blue, Purple, Yellow Rings), Check Valve, 0.2 Micron Filter, Clamp, Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein).

ICU Medical

Class I - Dangerous

The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.

May 30, 2017 Surgical Instruments View Details →

10" Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, Clamp, Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein).

ICU Medical

Class I - Dangerous

The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.

May 30, 2017 Surgical Instruments View Details →

168 cm (66") Appx 2.6 ml, PVC/PUR Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, MicroClave¿ Clear, Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein).

ICU Medical

Class I - Dangerous

The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.

May 30, 2017 Surgical Instruments View Details →

28 cm (11") PUR Bifuse Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, 2 NanoClave¿, Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein).

ICU Medical

Class I - Dangerous

The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.

May 30, 2017 Surgical Instruments View Details →

28 cm (11") PUR Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, NanoClave¿, Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein).

ICU Medical

Class I - Dangerous

The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.

May 30, 2017 Surgical Instruments View Details →

18 cm (7") PUR Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, NanoClave¿, Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein).

ICU Medical

Class I - Dangerous

The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.

May 30, 2017 Surgical Instruments View Details →

10" Smallbore Ext Set w/6-Port NanoClave¿ Manifold (Orange, Red, Blue, Purple, Yellow Rings), Check Valve, Clamp, Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein).

ICU Medical

Class I - Dangerous

The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.

May 30, 2017 Surgical Instruments View Details →

PROXIMALE - 28 cm (11") Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, NanoClave¿ (Red Rings), Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein)..

ICU Medical

Class I - Dangerous

The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.

May 30, 2017 Surgical Instruments View Details →

Kit w/3 Ext Sets, 3 Drop-In MicroClave¿ Clear. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein).

ICU Medical

Class I - Dangerous

The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.

May 30, 2017 Surgical Instruments View Details →

Jelco, Hypodermic needle Pro¿ needles 19G X1 1/2" 800/CA Model No. EL 1915 & 19G X 2" 600/CA Model No. SB 5021, Rx Only, Sterile EO.

Smiths Medical ASD

Class I - Dangerous

Smiths Medical became aware on January 11, 2017, that syringe assemblies provided by Nipro Medical Corporation contained pin holes in the side wall of the hub. The defect was not detected during Smiths Medical incoming inspection. The syringe assemblies were used to manufacture seven (7) finished good lots of Hypodermic Needle Pro¿ needles, Smiths Medical part numbers EL 1915 and SB5021.

Apr 4, 2017 Surgical Instruments View Details →

Electrophysiology catheter cables are designed as electrode cables with a multi-pin connector on the distal end and the appropriate number of tails on the proximal end. The cables serve two different purposes. They either serve as an extension between an EP catheter and equipment out of reach or they interface an EP catheter with the appropriate external stimulation of recording equipment.

Sterilmed

Class I - Dangerous

Sterilmed is recalling all lots of specific product codes of unexpired Sterilmed Reprocessed EP Ablation Cables because Sterilmed determined that the cables are Class III devices and thus require, but do not currently have, premarket review and approval.

May 8, 2017 Surgical Instruments View Details →
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