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Class 2 Device Recall 2008 Series Hemodialysis Machine

Class 2 Device Recall 2008 Series Hemodialysis Machine Fresenius Medical Care Renal Therapies is recalling its dialyzer, high permeability with or without sealed dialysate system, 2008 K2 Hemodialysis Machine with software version 5.40, Models: (1) Hemodialysis SYS OLC/Diasafe PLS 190610, UDI 00840861100859 (+Serial Number), (2) Machine Short Cap, OLC.DP HP 190630, UDI 00840861100866 (+Serial Number)

By | April 16th, 2018|alerts|0 Comments

BD Vacutainer Blood Collection Tubes: Class I Recall

BD Vacutainer Blood Collection Tubes by Becton, Dickinson and Company (BD): Class I Recall - Chemical Interference with Certain Tests ISSUE: BD is recalling their Vacutainer EDTA Blood Collection Tubes with lavender, tan, pink and green rubber tube stoppers due to a chemical in the rubber tube stopper that interferes with the accuracy of the

By | March 28th, 2018|alerts|0 Comments

Riomet – Metformin Hydrochloride Oral Solution

Riomet (Metformin Hydrochloride Oral Solution): Recall - Microbial Contamination ISSUE: Sun Pharmaceutical Industries is recalling two lots of Riomet (Metformin Hydrochloride Oral Solution), which were found to be contaminated with Scopulariopsis brevicaulis. Use of the affected Riomet potentially could result in a risk of infection, especially in the immunocompromised patient. The most plausible portal of

By | December 5th, 2017|alerts|0 Comments

Diabetes Infusion Sets by Medtronic

Recall - Vent Membrane May be Susceptible to Being Blocked by Fluid See the FDA Safety Alert ISSUE: Medtronic is informing patients worldwide of a voluntary recall of specific lots of infusion sets used with all models of Medtronic insulin pumps. The recall is related to a certain discontinued component in these infusion sets and does not

By | November 8th, 2017|alerts|0 Comments

FDA Recall – Class 2 Device Recall Baxter Amia Automated Peritoneal Dialysis Set with Cassette

Baxter Healthcare Corporation initiated a recall on the Amia Automated Peritoneal Dialysis Set with Cassette. The firm received increased customer complaints for Missing Red Line, Patient Slow Flow, Solution Slow Flow, and Inadequate Drain alerts. The patients and clinics were directed to locate and remove all affected product and to contact Baxter Healthcare Center for

By | November 6th, 2017|alerts|0 Comments