Skin Prep Tray

Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: DERMATOLOGY SHAVE KIT, Medline Kit SKU SK395

Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Webcol Large Alcohol Prep Pads to be non-sterile following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.

Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as:

Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.

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:

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.

Centurion procedure packs, containing Caina syringes, 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 SWABSTICKS PVP 3 PK, Product Code DYNDA2724

Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.

Medline Kits, trays, and packs labeled as follows:

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.

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.

FAST Procedure Kit.

American Optisurgical, Inc initiated a recall of ChloraPrep Hi-Lite Orange 3mL Applicator, in response to a sub-recall letter from Medline Industries, Inc due to lack of sterility assurance caused by an incomplete seal on the individual unit packaging.

Sepp, Compound Benzoin Tincture Packaged and Tincture 3,000 Bulk.

An internal review of CareFusion's labeling for preoperative skin prep product codes was recently conducted. The labeling of the product codes identified above state that the contents of the package are sterile and does not clarify that this sterility claim is only applicable to the applicator. The antiseptic solution that is applied to the skin is a cutaneous disinfectant, and is not sterilized.