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Showing 8561–8580 of 11714 results

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Medline Radiology Procedure 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

Bausch + Lomb Basic Ophthalmic 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

Stryker INBONE Tibial Tray (Wright Medical) – Lock Detail Issue (2022)

The tibial tray lock detail is oversized (larger than specification).

Moderate

FDASep 30, 2022Nationwide• Wright Medical Technology, Inc.

Medline CVC Barrier Kit (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

Bausch + Lomb Phaco 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

Centurion NICU PICC Insertion Bundle (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

TufTex Embolectomy Catheter (LeMaitre) – Ligature Strength Risk (2022)

Three lots tied by two trainees were released without performing the required pull test. If tied with inadequate strength, the proximal ligature could slip toward the tip of the catheter and block the inflation hole, leading to the risk of the tip breaking off, and potentially becoming lost in the blood vessel.

FDASep 30, 2022Nationwide• LeMaitre Vascular, Inc.

Beaver Arthro-Lok Blade (Beaver Visitec) – Blade Configuration Error (2022)

Incorrect configuration of the blades in the package. The blades curve to the right instead of curving to the left. If used may cause cause unintended tissue damage during the procedure or if noticed prior to use may cause a delay in surgery

FDASep 30, 2022FL, GA, IN +4 more• Beaver Visitec International, Inc.

Bausch + Lomb Cataract Tray (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

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.

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

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

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

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

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.

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

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

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

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

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