Tray, Start/stop (including Contents), Dialysis

Medline Kits containing Tego Connectors

Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.

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 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.

Centurion 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.

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.

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

Custom Dialysis prep kits labeled as follows:

The firm used alcohol triple swabstick and prep pads manufactured by H & P Industries in the manufacture of their custom dialysis kits. Those swabsticks and pads were subsequently recalled due to possible bacterial contamination.

Custom dialysis prep kits labeled as follows:

Firm manufactured custom dialysis kits with Povidone Iodine (PVP) Prep Pads which were recalled by H & P industries. Those pads were subsequently recalled due to possible bacterial contamination.

Dialysis On/Off Kit, DT11300, Sterile, Micropore Surgical Tape, Single Use Rolls, Port Access Dressing Change Tray, Tri-State Hospital Supply Company Manufactur

The 3M micropore tape is under recall due to the tape not performing and needles becoming loose and dislodged.

C.A.P.D. Tubing Exchange Tray, HT80, Sterile, Micropore Surgical Tape, Single Use Rolls, Tri-State Hospital Supply Company Manufacturers of Centurion Healthcare

The 3M micropore tape is under recall due to the tape not performing and needles becoming loose and dislodged.