Drape, Surgical, Antimicrobial

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 containing select SKUs of 10mL Polycarbonate Colored Syringes

Unapproved design changes to the products outside of the 510(k) clearance.

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.

Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029

Surgical drape packs may have open seals, which may compromise the sterility of the product.

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.

Brand Name: HALYARD

Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging.

Medline brand medical procedure convenience kits, labeled as:

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.

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.

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following:

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

Surgical convenience kits labeled as:

The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.