Smart Bag Flexpack Acid Concentrates

Brief description of the problem (reason for recall)

The recall is being initiated as the distributor for certain lots of SmartBag Flexpack Acid Concentrates identified a defective pump that was used in the manufacturing process. The defective pump has already been replaced but testing of prior produced Smartbags revealed sporadic presence of neodymium, a lanthanide metal which leached from the magnetic drive in the pump. Although a legal limit for neodymium is not provided, the level detected was evaluated in a toxicological risk assessment.

Advice for health professionals and distributors:

Fresenius Medical Care advises that you distribute this recall notice to everyone in your organisation who needs to be aware of it.

In case of any further questions do not hesitate to contact: medical-device-safety@freseniusmedicalcare.com

Please retain the letter in a prominent position for one month in case stock is in transit (where applicable).

“If any of the recalled stock could have been transferred from your hospital to another, please let that hospital know or alternatively inform our company so that we can make contact with the hospital supplied from your hospital”.

If you have any questions or require further information, please contact:

Nonhlanhla Nolly Sibiya

Fresenius Medical Care

Telephone: +(27) 79 515 6740

Email: Nolly.Sibiya@freseniusmedicalcare.com

Proposed action taken and its urgency: A SAHPRA-approved recall letter was distributed to all distribution points and the recall process was initiated.

Reporting side effects

Public and healthcare professionals are encouraged to report any side effects after using a health product or after immunisation by using the Med Safety App. Your report will contribute to our monitoring of these health products.