Port Introducer Kit

AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Port Tray - RX, Part Number 008786-19

Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplier quality issues.

Medical convenience kits

Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.

CENTRAL LINE PICC

ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.

Custom procedural convenience kits and trays, general hospital use, labeled as:

During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation stating the "piggybacked" components were assessed to determine if they were suitable for exposure to elevated temperatures for an extended period of time and further exposure to sterilization. As a result, the piggybacked components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) may have had higher than specified EO residuals.

Procedure packs:

Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).

Tri-State Hospital Supply Corp., Tri-State Centurion Venous Access Port Kits, Qty/case 20, sterile, Code No./Reorder KNV80. Each kit contains 1 sterile heparin

The kits contain Monoject prefill heparin lock flush syringes, which were recalled by the manufacturer due to contamination.

Tri-State Hospital Supply Corp., Tri-State Centurion Port Access Trays, Qty/case 20, sterile, Code no./reorder DT9405B. Each tray contains 1 sterile heparin

The kits contain Monoject prefill heparin lock flush syringes, which were recalled by the manufacturer due to contamination.

Tri-State Hospital Supply Corp., Tri-State Centurion Port Blood Draw Trays, Qty/case 20, sterile, Code no./reorder DT9410B. Each tray contains 1 sterile hepari

The kits contain Monoject prefill heparin lock flush syringes, which were recalled by the manufacturer due to contamination.

Tri-State Hospital Supply Corp., Tri-State Centurion Port Access Trays, Qty/case 20, sterile, Code no./reorder KNV50. Each tray contains 1 sterile heparin flus

The kits contain Monoject prefill heparin lock flush syringes, which were recalled by the manufacturer due to contamination.

Various Port Insertion Packs

Product was exposed to multiple sterilization cycles without validation for multiple exposures.