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Showing 6301–6320 of 8393 results

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NovoTHOR Gen 2.5 (Thor) – Gas Strut Detachment (2022)

Failure of ball stud components causing the gas strut on one side to detach from the canopy, making the canopy difficult to lift.

FDASep 13, 2022Nationwide• Thor Photomedicine Ltd Watermeadow House Chesham United Kingdom

NovoTHOR Gen 2.5 XL (Thor) – Gas Strut Detachment (2022)

Failure of ball stud components causing the gas strut on one side to detach from the canopy, making the canopy difficult to lift.

FDASep 13, 2022Nationwide• Thor Photomedicine Ltd Watermeadow House Chesham United Kingdom

Orthex Large Bone Shoulder Bolt (OrthoPediatrics) – Bolt Breakage (2022)

Bolt breakage on the head or threaded portion, which may cause loss of strut continuity with frame. This may cause loss of deformity correction and/or disruption of bone regeneration.

High

FDASep 12, 2022Nationwide• OrthoPediatrics Corp

Blood Culture Kit (Medline) – Expiration Mismatch (2022)

Adult Blood Culture Collect kit and Pre-Op Changing Bathing Kit contain an incorrect expiration date on a component with the kit. CHG Solution with the Pre-Op Changing Bathing Kit and Bactec bottle plastic both have an expiration date that does not match the date listed on the kit.

FDASep 9, 2022Nationwide• MEDLINE INDUSTRIES, LP Northfield

Peripheral Blood Culture Draw (Medline) – Expiration Mismatch (2022)

Adult Blood Culture Collect kit and Pre-Op Changing Bathing Kit contain an incorrect expiration date on a component with the kit. CHG Solution with the Pre-Op Changing Bathing Kit and Bactec bottle plastic both have an expiration date that does not match the date listed on the kit.

FDASep 9, 2022Nationwide• MEDLINE INDUSTRIES, LP Northfield

24 Blood Culture Kit (Medline) – Expiration Mismatch (2022)

Adult Blood Culture Collect kit and Pre-Op Changing Bathing Kit contain an incorrect expiration date on a component with the kit. CHG Solution with the Pre-Op Changing Bathing Kit and Bactec bottle plastic both have an expiration date that does not match the date listed on the kit.

FDASep 9, 2022Nationwide• MEDLINE INDUSTRIES, LP Northfield

Blood Culture Collect Kit (Medline) – Expiration Mismatch (2022)

Adult Blood Culture Collect kit and Pre-Op Changing Bathing Kit contain an incorrect expiration date on a component with the kit. CHG Solution with the Pre-Op Changing Bathing Kit and Bactec bottle plastic both have an expiration date that does not match the date listed on the kit.

FDASep 9, 2022Nationwide• MEDLINE INDUSTRIES, LP Northfield

Pre-Op CHG Bathing Kit (Medline) – Expiration Mismatch (2022)

Adult Blood Culture Collect kit and Pre-Op Changing Bathing Kit contain an incorrect expiration date on a component with the kit. CHG Solution with the Pre-Op Changing Bathing Kit and Bactec bottle plastic both have an expiration date that does not match the date listed on the kit.

FDASep 9, 2022Nationwide• MEDLINE INDUSTRIES, LP Northfield

MitraClip NTR (Abbott) – Clip Locking Malfunction (2022)

An increase in clip locking malfunctions, Establish Final Arm Angle and Clip Opening While Locked, have been observed. Contributing causes may be clip locking component material properties and certain use conditions. Unsuccessful clip procedure can lead to recurrence of severe mitral regurgitation, device embolization, or tissue injury.

FDASep 8, 2022Nationwide• Abbott Vascular

MitraClip G4 CDS (Abbott) – Clip Locking Malfunction (2022)

An increase in clip locking malfunctions, Establish Final Arm Angle and Clip Opening While Locked, have been observed. Contributing causes may be clip locking component material properties and certain use conditions. Unsuccessful clip procedure can lead to recurrence of severe mitral regurgitation, device embolization, or tissue injury.

FDASep 8, 2022Nationwide• Abbott Vascular

MitraClip XTR (Abbott) – Clip Locking Malfunction (2022)

An increase in clip locking malfunctions, Establish Final Arm Angle and Clip Opening While Locked, have been observed. Contributing causes may be clip locking component material properties and certain use conditions. Unsuccessful clip procedure can lead to recurrence of severe mitral regurgitation, device embolization, or tissue injury.

FDASep 8, 2022Nationwide• Abbott Vascular

Thermocool SmartTouch Catheter (J&J) – Contamination Risk (2022)

Manufacturing error resulted in potential contamination of Bi-Directional navigation catheter irrigation path with cellulose fibers that can cause 1) Failure of initial flushing inspection, 2) Insufficient irrigation causing catheter tip temperature increase, limiting the ability to deliver ablation, or 3) particles flushed through the catheter irrigation may have thrombogenic/toxic effect.

FDASep 7, 2022Nationwide• Johnson & Johnson Surgical Vision, Inc.

Optima Coil System (BALT) – Label Mismatch (2022)

Product pouch label does not match up with carton label

FDASep 7, 2022Nationwide• BALT USA, LLC

DreamWisp Nasal Mask (Philips) – Magnetic Component Warning (2022)

No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes.

FDASep 6, 2022Nationwide• Philips Respironics, Inc.

Therapy Mask 3100 (Philips) – Magnetic Component Warning (2022)

No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes.

FDASep 6, 2022Nationwide• Philips Respironics, Inc.

MR Patient Care Portal (Philips) – Audio Failure (2022)

Device may intermittently fail to produce audio. Turning the unit off and on does not resolve the issue; disconnecting and reconnecting to AC power does not reliably resolve the issue.

FDASep 6, 2022AL, AZ, CA +22 more• Philips North America Llc

Amara View Mask (Philips) – Magnetic Component Warning (2022)

No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes.

FDASep 6, 2022Nationwide• Philips Respironics, Inc.

DreamWear Full Face Mask (Philips) – Magnetic Component Warning (2022)

No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes.

FDASep 6, 2022Nationwide• Philips Respironics, Inc.

Wisp Nasal Mask (Philips) – Magnetic Component Warning (2022)

No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes.

FDASep 6, 2022Nationwide• Philips Respironics, Inc.

Starling Monitor (Baxter) – Labeling Compliance (2022)

Labeling has incorrect or incomplete Unique Device Identification (UDI) information; and the barcodes are not compliant with GS-1 standards.

FDASep 2, 2022Nationwide• Baxter Healthcare Corporation

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