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Showing 7941–7960 of 8389 results

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Coltene Whaledent Inc: CEI Cutting Edge Instruments (PTC-57C)

The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs.

FDAOct 20, 2020FL, IN, NV +3 more• Coltene Whaledent Inc

Coltene Whaledent Inc: Alpen Clinic 100 Carbide Instruments (R100057C)

The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs.

FDAOct 20, 2020FL, IN, NV +3 more• Coltene Whaledent Inc

Coltene Whaledent Inc: Strauss 25 Carbide Dental Burs (100057XXV)

The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs.

FDAOct 20, 2020FL, IN, NV +3 more• Coltene Whaledent Inc

Coltene Whaledent Inc: Clinic Pack 100 Pieces FG 57 100057C (100057C)

The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs.

FDAOct 20, 2020FL, IN, NV +3 more• Coltene Whaledent Inc

Coltene Whaledent Inc: FG 57 100057X (100057X)

The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs.

FDAOct 20, 2020FL, IN, NV +3 more• Coltene Whaledent Inc

Ortho Clinical Diagnostics Inc: VITROS Chemistry Products Performance Verifier II-For in ...

Product instability; biased ALKP values obtained from VITROS Chemistry Products Performance Verifier II Lot Q7692 when stored unopened at refrigerated temperatures

FDAOct 16, 2020Nationwide• Ortho Clinical Diagnostics Inc

Covidien Llc: Puritan Bennett 980 (PB980) Ventilator Series - Product U...

In-house lab observations and customer reports of overheating and/or thermal damage to the battery pack, create the risk of exposure to smoke or hazardous materials, which may result in burns and/or bronchospasm,

FDAOct 16, 2020Nationwide• Covidien Llc

Tytek Medical Inc: TyTek PneumoDart- Intended for introduction into the body...

Updated IFU to inlclude: (1) identify the risks associated with the hazard of needle decompression and (2) improve the artwork showing placement site location

FDAOct 5, 2020OH, SC, VA• Tytek Medical Inc

Tytek Medical Inc: TyTek Tension Pneumothorax Access Kit TPAK 14 gauge 3.25 ...

Updated IFU to inlclude: (1) identify the risks associated with the hazard of needle decompression and (2) improve the artwork showing placement site location

FDAOct 5, 2020OH, SC, VA• Tytek Medical Inc

Epitope Diagnostics, Inc.: EDI Novel Coronavirus COVID-19 IgG ELISA Kit, REF: KT-103...

The use of deionized water rather than distilled water during the manufacturing process, may have resulted in accelerated decreased OD signals for the Positive Control value.

FDAOct 1, 2020CA, CO, FL +17 more• Epitope Diagnostics, Inc.

Merz North America, Inc.: COAPTITE Injectable Implant, injectable, sterile, non-pyr...

The Instructions for Use (IFU) updated 03/02/2020 does not match data listed in the post-approval study.

FDASep 30, 2020AL, AZ, AR +45 more• Merz North America, Inc.

Stryker GmbH Bohnackerweg 1 Selzach Switzerland: Osteosynthesis Compression Staple EasyClip

The device has the potential to release nickel above the acceptable margin of safety in pediatric patients who weigh less than 20 kg (44.09 lbs) when 2 or more implants are used.

FDASep 25, 2020Nationwide• Stryker GmbH Bohnackerweg 1 Selzach Switzerland

Boston Scientific Corporation: AMS 700 MS Pump with and without InhibiZone, sold as indi...

The recalling firm has observed an increase in complaints of problems encountered during the initial activation of the device in which the patient and/or the physician is unable or has difficulty activating the pump in order to achieve cylinder inflation.

FDASep 24, 2020Nationwide• Boston Scientific Corporation

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.): Streamline OCT Navigated Instruments, Catalog numbers 26-...

System does not include a drill guide.

FDASep 24, 2020IN, MI• RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

Siemens Healthcare Diagnostics, Inc.: ADVIA Chemistry Systems-Fructosamine (FRUC)-For in vitro ...

Fructosamine QC and patient samples may exhibit a 60 umol/L positive bias across the measuring range compared to predicate assay reference leading to a potential adjustment of hyperglycemic therapy. Positively biased fructosamine results may prompt changes in glucose management that may affect glycemia. In extreme situations, more aggressive management of glycemia may occur and contribute to hypoglycemia.

FDASep 22, 2020CA, DE, MD +4 more• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: Atellica CH Systems Fructosamine (FRUC)-For in vitro diag...

Fructosamine QC and patient samples may exhibit a 60 umol/L positive bias across the measuring range compared to predicate assay reference leading to a potential adjustment of hyperglycemic therapy. Positively biased fructosamine results may prompt changes in glucose management that may affect glycemia. In extreme situations, more aggressive management of glycemia may occur and contribute to hypoglycemia.

FDASep 22, 2020CA, DE, MD +4 more• Siemens Healthcare Diagnostics, Inc.

Cardinal Health: Kangaroo Connect 1000ml Bag Set, Non-Sterile, Product Cod...

The feeding spike sets may leak at the interface of the tube and spike connector.

FDASep 22, 2020Nationwide• Cardinal Health

Cardinal Health: Kangaroo Connect 500ml Bag Set, Non-Sterile, Product Code...

The feeding spike sets may leak at the interface of the tube and spike connector.

FDASep 22, 2020Nationwide• Cardinal Health

Smith & Nephew, Inc.: Genesis (GII) - Product Usage: designed for use in patien...

The anterior locking detail does not meet its design specifications.

FDASep 21, 2020Nationwide• Smith & Nephew, 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

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