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Showing 7961–7980 of 8393 results

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GE Healthcare, LLC: Flow Sensor Service Part, Catalog 2089610-001-S

Laceration Risk

Flow sensors could have damaged tubes in the form of small punctures or cuts.

FDASep 17, 2020AL, AZ, AR +33 more• GE Healthcare, LLC

GE Healthcare, LLC: 9100c NXT system - Product Usage: Device is licensed and ...

Laceration Risk

Flow sensors could have damaged tubes in the form of small punctures or cuts.

FDASep 17, 2020AL, AZ, AR +33 more• GE Healthcare, LLC

THREAD COUNSEL INC DBA LAWS OF MOTION: LOM Disposable Surgical Gowns/Medical Gowns, Single-Use

Medical gowns distributed to customers did not include appropriate labeling, and some gowns may not meet FDA's standards for surgical gowns.

FDASep 17, 2020IN, NY• THREAD COUNSEL INC DBA LAWS OF MOTION

Genicon, Inc.: A Li-Gator Single Use Laparoscopic Clip Applier, 10 mm X ...

Device malfunction causing the applier to jam, and clip loading failures.

FDASep 17, 2020Nationwide• Genicon, Inc.

GE Healthcare, LLC: GE Datex-Ohmeda Aisys CS2 Anesthesia System - Product Usa...

Laceration Risk

Flow sensors could have damaged tubes in the form of small punctures or cuts.

FDASep 17, 2020AL, AZ, AR +33 more• GE Healthcare, LLC

GE Healthcare, LLC: GE Datex-Ohmeda Avance CS2 Anesthesia System - Product Us...

Laceration Risk

Flow sensors could have damaged tubes in the form of small punctures or cuts.

FDASep 17, 2020AL, AZ, AR +33 more• GE Healthcare, LLC

Getinge Group Logistics America, LLC: Servo-i Ventilator, Part No. 6487800, UDI Code 0732571000...

A potentially shorter than specified nebulizer connector may result in difficulty in installing the Aeroneb Nebulizer module to the Servo-i device successfully.

FDASep 17, 2020AZ, CA, GA +12 more• Getinge Group Logistics America, LLC

Boston Scientific Corporation: Hurricane RX Biliary Balloon Dilatation Catheter Catalog ...

RX tunnel component (black sheath) may detach from the catheter shaft due to lower bond strength.

FDASep 16, 2020Nationwide• Boston Scientific Corporation

Medline Industries Inc: Quick Release Gait Belt, 60

The buckle on the Gait Belt may break due to degradation of the material due to exposure to gamma radiation.

FDASep 15, 2020IL, MI• Medline Industries Inc

Fujifilm Medical Systems U.S.A., Inc.: Synapse PACS Software Versions 5.1 and higher

There is a potential for the wrong patient information may be displayed in the viewer or PowerJacket. Additionally, the incorrect max standard uptake values (SUV) for PET ad CT studies may be returned for Siemens Modality.

FDASep 11, 2020Nationwide• Fujifilm Medical Systems U.S.A., Inc.

Bien-Air Surgery Sa rue de l' ouest 2b Le Noirmont Switzerland: Bien-Air Surgery REF 1600686-001 SN ******* OSSEOSTAP Foo...

The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.

FDASep 11, 2020Nationwide• Bien-Air Surgery Sa rue de l' ouest 2b Le Noirmont Switzerland

Bien-Air Surgery Sa rue de l' ouest 2b Le Noirmont Switzerland: Bien-Air Surgery REF 1600407-001 SN **** FOOTCTRL OSSEODO...

The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.

FDASep 11, 2020Nationwide• Bien-Air Surgery Sa rue de l' ouest 2b Le Noirmont Switzerland

Bien-Air Surgery Sa rue de l' ouest 2b Le Noirmont Switzerland: Entellus Medical REF SSA-102 SN ******* Shaver System Foo...

The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.

FDASep 11, 2020Nationwide• Bien-Air Surgery Sa rue de l' ouest 2b Le Noirmont Switzerland

Bien-Air Surgery Sa rue de l' ouest 2b Le Noirmont Switzerland: Bien-Air Surgery REF 1600517-001 SN ******* MULTIFUNCTION...

The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.

FDASep 11, 2020Nationwide• Bien-Air Surgery Sa rue de l' ouest 2b Le Noirmont Switzerland

Bien-Air Surgery Sa rue de l' ouest 2b Le Noirmont Switzerland: Stryker Instruments REF 5452-007-000 SN ******* S2 MINI ...

The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.

FDASep 11, 2020Nationwide• Bien-Air Surgery Sa rue de l' ouest 2b Le Noirmont Switzerland

Tandem Diabetes Care Inc: t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM, and t:s...

Insulin pumps may display unexpected fluctuation of the remaining battery life so ensure pump battery life does not fall below 25% remaining power. If the battery life drops to less than 5%, insulin delivery will continue for 30 minutes and then the pump will power off and insulin delivery will stop. If the battery reaches 1%, then insulin delivery will stop, which could lead to hyperglycemia.

FDASep 10, 2020IN• Tandem Diabetes Care Inc

Smith & Nephew, Inc.: MICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture a...

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

FDASep 9, 2020Nationwide• Smith & Nephew, Inc.

Smith & Nephew, Inc.: TWINFIX ULTRA PLLA HA 5.5MM W/ NEEDLES- Absorbable Suture...

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

FDASep 9, 2020Nationwide• Smith & Nephew, Inc.

Smith & Nephew, Inc.: HEALICOIL RG SA 5.5MM W/3 UB-BL CB BL BK- Absorbable Sutu...

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

FDASep 9, 2020Nationwide• Smith & Nephew, Inc.

Smith & Nephew, Inc.: HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL- Absorbable Sutu...

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

FDASep 9, 2020Nationwide• Smith & Nephew, Inc.

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