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Showing 6241–6260 of 8389 results

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Bausch + Lomb Eye Pack (Medline) – Seal Opening Risk (2022)

Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.

FDASep 30, 2022Nationwide• MEDLINE INDUSTRIES, LP Northfield

EMBLEM S-ICD (Boston Scientific) – Battery Capacity Error (2022)

There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity.

FDASep 30, 2022Nationwide• Boston Scientific Corporation

Canon Aplio Ultrasound (Canon) – Stress Echo Termination Problem (2022)

After completion, ultrasound system's Stress Echo may not terminate if user does not manually terminate the protocol. During next patient exam, an abnormal confirmation message will be displayed "Same view was saved in this phase. Do you use this image with StressEcho Review?" If "no", acquired images not saved, and if "yes" images assigned to the previous patient; could cause treatment delay.

Moderate

FDASep 29, 2022AR, CA, CO +20 more• Canon Medical System, USA, INC.

K-ASSAY IgA Immunoturbidimetric (Kamiya) – Reagent Cloudiness (2022)

IgA Reagent may start showing cloudiness over time, which can affect assay performance.

FDASep 28, 2022Nationwide• Kamiya Biomedical Company, LLC

Cardinal Health Gel Pack (Cardinal Health) – Infant Use Warning (2022)

Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on Infants/Neonates .

FDASep 28, 2022Nationwide• Cardinal Health 200, LLC

X-Guide X-Mark Probe (X-NAV) – Probe Attachment Risk (2022)

Product missing one of two welds connecting the tip to the shaft, if the remaining weld breaks, it is possible that the tip could fall out during X-Mark registration and fall into the patient s mouth. In this case, the patient may aspirate or swallow the probe tip.

FDASep 28, 2022Nationwide• X-NAV Technologies, LLC

Cardinal Health Gel Pack (Cardinal Health) – Infant Use Warning (2022)

Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on Infants/Neonates .

FDASep 28, 2022Nationwide• Cardinal Health 200, LLC

Endo Stitch V-Loc 180 (Unknown) – Needle Breaking Risk (2022)

Medtronic has received 210 reports of needles breaking during endoscopic suturing. The potential harm(s) include a delay in treatment/therapy, the potential for a portion of the needle to remain in the patient, foreign body reaction, allergic reaction, tissue injury and unintended radiation exposure from additional imaging for both intra-op and postoperative scenarios.

FDASep 28, 2022Nationwide

Endo Stitch V-Loc PBT (Unknown) – Needle Breaking Risk (2022)

Medtronic has received 210 reports of needles breaking during endoscopic suturing. The potential harm(s) include a delay in treatment/therapy, the potential for a portion of the needle to remain in the patient, foreign body reaction, allergic reaction, tissue injury and unintended radiation exposure from additional imaging for both intra-op and postoperative scenarios.

FDASep 28, 2022Nationwide

biokitHSV-2 Rapid Test (Biokit) – False Positive Risk (2022)

HSV-2 rapid test may report false positive results.

FDASep 28, 2022Nationwide• Biokit, S.A. Avinguda De Can Montcau 7 (Barcelona) Llica D'Amunt Spain

Zio AT Monitor (iRhythm) – ECG Notification Delay (2022)

Ambulatory ECG monitoring system labeling update: 1) Clinically actionable arrhythmia notifications delayed until patient registration is complete; 2) Patches limited to 100 symptomatic and 500 asymptomatic wireless transmissions; once the maximum transmission limit is reached for either type, any further transmissions for that type will cease. Risk of delayed reporting to health providers.

FDASep 28, 2022AL, AZ, AR +45 more• iRhythm Technologies, Inc.

Cardinal Health Gel Pack (Cardinal Health) – Infant Use Warning (2022)

Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on Infants/Neonates .

FDASep 28, 2022Nationwide• Cardinal Health 200, LLC

Pilling Wecksorb Sponges (Teleflex) – Sterility Compromise (2022)

Specific lots have not been irradiated to eliminate pyronema and therefore the sterility of the affected products may be compromised.

FDASep 28, 2022IL, MS, PA +1 more• TELEFLEX LLC

Cardinal Health Gel Pack (Cardinal Health) – Infant Use Warning (2022)

Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on Infants/Neonates .

FDASep 28, 2022Nationwide• Cardinal Health 200, LLC

SPEEDSHIFT Implant Drill Kit (Synthes) – Incorrect Drill Guide (2022)

The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant included in the sterile kit. If the incorrect drill guide is used, there is potential for bone damage due to incorrectly placed drill holes for the implant included in the kit.

FDASep 27, 2022Nationwide• Synthes (USA) Products LLC

SPEED Compression Implant (Synthes) – Incorrect Drill Guide (2022)

The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant included in the sterile kit. If the incorrect drill guide is used, there is potential for bone damage due to incorrectly placed drill holes for the implant included in the kit.

FDASep 27, 2022Nationwide• Synthes (USA) Products LLC

DePuy Synthes Hammertoe Implants (Synthes) – Incorrect Drill Guide (2022)

The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant included in the sterile kit. If the incorrect drill guide is used, there is potential for bone damage due to incorrectly placed drill holes for the implant included in the kit.

FDASep 27, 2022Nationwide• Synthes (USA) Products LLC

SPEED Compression Implant (Synthes) – Incorrect Drill Guide (2022)

The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant included in the sterile kit. If the incorrect drill guide is used, there is potential for bone damage due to incorrectly placed drill holes for the implant included in the kit.

FDASep 27, 2022Nationwide• Synthes (USA) Products LLC

CareFusion Genesis Quarter-Length Container (CareFusion) – Sterilization Test Failure (2022)

Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing.

FDASep 26, 2022Nationwide• Carefusion 2200 Inc 75 N Fairway Dr Vernon Hills IL 60061-1845

CareFusion Genesis Full-Length Container (CareFusion) – Sterilization Test Failure (2022)

Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing.

FDASep 26, 2022Nationwide• Carefusion 2200 Inc 75 N Fairway Dr Vernon Hills IL 60061-1845

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