0.9% Sodium Chloride Infusion B. Braun solution for infusion (9mg/ ml sodium chloride)

Reason for recall

B.Braun in consultation with the SAHPRA has taken a decision to recall their 0.9 % Sodium Chloride Infusion solution due to cross-contamination.  They have  been informed by their mother company in Germany regarding batches of solutions for infusion produced after Midazolam solution for infusion were detected to be cross-contaminated with traces of Midazolam above the PDE (Permitted Daily Exposure).

Advice to HCPs/Distributors/Public:

The company has requested the following from their customers:

• Do a visual check of the above-mentioned batches and separate
• Contact the customer you have supplied and arrange for return of the product to the hub if you are a wholesaler or distributor of the product. B.Braun will collect from your facility.
• Contact the B.Braun Customer Services Interaction Center for upliftment of the relevant

Proposed action taken and its urgency: Any remaining stock is to be quarantined, stock is to be blocked for sale by all distributors. The SAHPRA approved recall letter is to be distributed to all clients and recall process initiated as per recall guideline.

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.