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Showing 8301–8320 of 8393 results

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New Standard Device Inc: Metalogix Slotted 90 Tubular Wrench x 10mm REF 900104 LOT...

Due to manufacturing processing error, wrench causing stripping when torqueing nuts.

FDAAug 14, 2019AZ, CT, GA +2 more• New Standard Device Inc

GE Healthcare, LLC: Proteus XR/a (SlOK : K993090)

Intermittently not receiving an audible exposure indication upon completion of an exposure on the Proteus stationary radiographic system.

FDAAug 9, 2019Nationwide• GE Healthcare, LLC

Medline Industries Inc: Medline SYRINGE, PISTON,IRR TRAY,W/.9, REF DYNC2303. Ste...

Samples in the identified lot were found to have incomplete or open packaging seals.

FDAAug 9, 2019Nationwide• Medline Industries Inc

Imactis 20 Rue Du Tour De L Eau St Martin D Heres France: Imactis Navigation Kit, REF 10100, Content Sterile Needle...

The firm has become aware that the sensor cover, a component of the single-use navigation kit may contain microbial contamination. A source of microbial contamination has been identified in a raw product used to manufacture the tip of the cover.This could result in direct exposure of the intra-cardiovascular, intra-lymphatic or neurological system to a level of endotoxin sufficient to produce a pyrogenic response.

FDAAug 1, 2019IL, WI• Imactis 20 Rue Du Tour De L Eau St Martin D Heres France

GN Otometrics Horskatten 9 Taastrup Denmark: Gold Cup Leadwire and Snap Leadwire with the following co...

The electrode lead connector has a protruding conductor beyond insulation of approximately 0.1 mm.

FDAAug 1, 2019Nationwide• GN Otometrics Horskatten 9 Taastrup Denmark

Eizo Corporation Eizo Kabu Hakusan Japan: RadiForce GX560 monochrome LCD monitor, models 0FTD2347 a...

Under certain conditions, a marble pattern infrequently appears on the monitor.

FDAJul 30, 2019Nationwide• Eizo Corporation Eizo Kabu Hakusan Japan

Eizo Corporation Eizo Kabu Hakusan Japan: RadiForce RX360, model 0FTD2346 - Product Usage: is a col...

Under certain conditions, a marble pattern infrequently appears on the monitor.

FDAJul 30, 2019Nationwide• Eizo Corporation Eizo Kabu Hakusan Japan

MOTEK MEDICAL B.V. Hogehilweg 18 18 Unit C Amsterdam Netherlands: Body Weight Support (BWS) Light; Model No. RB011; a compo...

The firm discovered a potential manufacturing deviation of the yoke of the Body Weight Support (BWS) Light that in rare occasions may result in the yoke detaching from the cable guide.

FDAJul 29, 2019Nationwide• MOTEK MEDICAL B.V. Hogehilweg 18 18 Unit C Amsterdam Netherlands

GE Healthcare, LLC: Giraffe OmniBed Carestation CS1 - Product Usage: The devi...

Fasteners potentially torqued to a value less than the specified value and can potentially cause the canopy to become detached and fall.

FDAJul 26, 2019Nationwide• GE Healthcare, LLC

Allergan PLC: Natrelle133 Plus Tissue Expander With/Without Suture Tabs...

The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.

FDAJul 24, 2019Nationwide• Allergan PLC

Allergan PLC: Natrelle, Saline-Filled Breast Implant Biocell Full Heigh...

The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.

FDAJul 24, 2019Nationwide• Allergan PLC

Allergan PLC: Komuro, Soft Touch, BIOCELL, INTRASHIEL, BioDIMENSIONAL b...

The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.

FDAJul 24, 2019Nationwide• Allergan PLC

Allergan PLC: Natrelle Inspira, Silicone-Filled Breast Implants, Steril...

The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.

FDAJul 24, 2019Nationwide• Allergan PLC

Allergan PLC: RITZ PRINCESS, BIOCELL, INTRASHIEL, BioDIMENSIONAL Breast...

The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.

FDAJul 24, 2019Nationwide• Allergan PLC

Allergan PLC: McGhan Croissant-Shaped Tissue Expanders, Style 134 Pr...

The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.

FDAJul 24, 2019Nationwide• Allergan PLC

Allergan PLC: Natrelle 410, Highly Cohesive Anatomically Shaped Silicon...

The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.

FDAJul 24, 2019Nationwide• Allergan PLC

Allergan PLC: Natrelle 150 Full Height and Short Height Implants, BIOCE...

The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.

FDAJul 24, 2019Nationwide• Allergan PLC

Allergan PLC: Natrelle 510, TruForm, Dual-Gel, BIOCELL, Styles LX, MX, ...

The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.

FDAJul 24, 2019Nationwide• Allergan PLC

Allergan PLC: Natrelle and McGhan Silicone-Filled Breast Implant BioCel...

The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.

FDAJul 24, 2019Nationwide• Allergan PLC

Allergan PLC: Natrelle 133 Tissue Expanders (also named style 133 BIOSP...

The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.

FDAJul 24, 2019Nationwide• Allergan PLC

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