Saline Flush Syringe compromised sterility due to holes in the packaging.
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Surgical Instruments
🏥 Medical Devices • 6,839 recalls
Saline Flush Syringe compromised sterility due to holes in the packaging.
Saline Flush Syringe compromised sterility due to holes in the packaging.
PowerGlide ST Midline Catheter Maximal Barrier Kit-18 gauge,10 cm length Catalog Number: ST018101D
Becton Dickinson & Company
Class I - Dangerous
Iincorrectly packaged without the required lidocaine as labeled
The products have the potential to leak between the connection of the male luer and the yellow striped tubing. This leak may be observed while priming or during use. The most likely health consequence associated with a leak in an administration set would be inadequate pain control for the patient due to an under-infusion of medication.
When analyzer sample carousel lid remains open or manual process is too long, Module timeout expiry errors could occur causing cross contamination of samples.
Saline Flush Syringe compromised sterility due to holes in the packaging.
Saline Flush Syringe compromised sterility due to holes in the packaging.
There is potential for a white paper-type residue attached to the catheter.
Class I - Dangerous
Arterial Line Kits include thicker curved reverse-cutting needle with a 0-silk suture, instead of the usual straight-cutting needle with a 3-0 silk suture. The thicker suture may be more difficult to tie. The curved needle requires the use of a needle driver, there is a risk of needle stick to the surgeon tries to do it with fingers instead.
Saline Flush Syringe compromised sterility due to holes in the packaging.
Saline Flush Syringe compromised sterility due to holes in the packaging.
Class I - Dangerous
Arterial Line Kits include thicker curved reverse-cutting needle with a 0-silk suture, instead of the usual straight-cutting needle with a 3-0 silk suture. The thicker suture may be more difficult to tie. The curved needle requires the use of a needle driver, there is a risk of needle stick to the surgeon tries to do it with fingers instead.
Class I - Dangerous
The firm has received reports of tip separation during usage of the catheters, which may expose patients to unintended dislodgement of the tip from the body of the catheter.
Class I - Dangerous
The firm became aware of a manufacturing variation in which black and green reloads in select Stapler Reloads may not deploy individual adjacent staples, which could result in an incomplete staple line. Failure of a incomplete staple like could potentially lead to an air leak or an anastomotic leak which may require an additional procedural intervention.
During an FDA audit, it was discovered that the product was not properly registered with FDA.
Class I - Dangerous
The firm received complaints on the saline tubing of Visualase Cooled Laser Applicator System (VCLAS) kit, including incorrect Luer connector assembly, incorrect drip-chamber assembly, and/or excessive adhesive causing tubing occlusion, all of which could result in disruption or prevention of saline flow.
During an FDA audit, it was discovered that the product was not properly registered with FDA.
da Vinci SP Instrument Arm Drape. REF 430013-12 QTY 1 Pouch
Intuitive Surgical
Class I - Dangerous
The instrument drape may tear while draping the Patient Side Cart presenting a breach in the sterile barrier.
Class I - Dangerous
The firm became aware of a manufacturing variation in which black and green reloads in select Stapler Reloads may not deploy individual adjacent staples, which could result in an incomplete staple line. Failure of a incomplete staple like could potentially lead to an air leak or an anastomotic leak which may require an additional procedural intervention.