Tracheotomy Care Kit

Medline Convenience Kits:

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

Medline Convenience Kits:

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

Medline Convenience kits used for various procedures:

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

MEDLINE convenience kits labeled as:

Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.

Medline Convenience kits, labeled as:

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

MEDLINE TRAY care and cleaning kits and trays for Tracheostomy and Stomas, labeled as:

Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.

Catalog No. 800 TRACHEOSTOMY CARE TRAY - STERILE -LATEX FREE

Firm is recalling all kits containing recalled lots of Nurse Assist Sterile 0.9% Normal Saline. Nurse Assist identified product in distribution for which the required sterility assurance level (SAL) of 10^-6 cannot be guaranteed. Risks to patients if product is used include blood stream infections, urinary tract infections, or respiratory infections; in the worst-case scenario, there is risk of sepsis or death.

Catalog No. 9251R1, 9251R2, 9251R3

Firm is recalling all kits containing recalled lots of Nurse Assist Sterile 0.9% Normal Saline. Nurse Assist identified product in distribution for which the required sterility assurance level (SAL) of 10^-6 cannot be guaranteed. Risks to patients if product is used include blood stream infections, urinary tract infections, or respiratory infections; in the worst-case scenario, there is risk of sepsis or death.

TRACH PACK. Sterile Procedural Tray.

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Catalog Number: 900110 TRACHEOSTOMY CARE KIT WITH TRACH TUBE HOLDER FOR ADULT

Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.