Content with tag field safety notice recall.

Class 3 Recall - Field Safety Notice on Super Absorbent Dressing

Richardson Healthcare has released a field safety notice for the below batches of Super Absorbent Dressing after carrying out a stock check of the Sterile Super Absorbent Dressing and found the afore...

Field Safety Notice on CoaguChek

Roche Diagnostics has issued a Field Safety Notice on the batches below due to an increase in complaints regarding deviations against laboratory methods during the last weeks. Therefore, Roche...

Field Safety Notice on Medset CM Breast Pump Kit

Medela AG found that labelling documentation for the Medset CM Breast Pump Kit is incomplete. Additionally, although all product is sterile, we cannot demonstrate full compliance with the quality...

Field Safety Notice on Accu-Chek Aviva & Performa Test Strips

Roche have identified certain test strips lots that potentially show an increase in strip errors prior dosing. Due to the designed fail-safe in the blood glucose meter, the issue can be identified by...

Field Safety Notice on Askina Gel & Askina Calgitrol Paste

It was determined that the irradiation dose qualified for sterilization of the above mentioned products was too low. In consequence, the germ reduction through gamma irradiation may not have reached...

Field Safety Notice on Biatain Ibu & Biatain Ag

The sterility of mentioned medical devices made by Coloplast may be compromised due to a quality issue that has occurred in the production process. Investigations to find the root cause and to solve...

Field Safety Notice on Microdot Droplet Pen Needles

This is a Field Safety Notice, there is a precautionary notice on the use of the needles – some needles have been identified slightly bent.

Field Safety Notice Recall on Hydrosil Catheter

Bard Medical Division has identified that the product code/lot number combination listed above may have a sterile barrier breach where the catheter may be caught in the seal or protruding from the...