Baxter Healthcare Ltd Prismaflex Sets – Third Party Sterilization Report Falsification (ICN 1363)

Recall Ref: 43

Alert:      

• Baxter Healthcare Ltd used Steril Milano, a third-party contract supplier of sterilisation services, between May and July 2020 to sterilise the lots of Prismaflex Sets listed below due to product processing capacity issues during the Covid-19 pandemic.
• Baxter was notified that Steril Milano provided inaccurate and/or false documentation related to its sterilization processes. These deviations are related to the parameters and processes defined for Ethylene Oxide sterilisation.
• Although an internal Baxter analysis determined that sterility of these product lots was not impacted by the documentation issue, as a precaution, and in collaboration with the notified body BSI, Baxter is recalling all lots of product sterilised by Steril Milano in the United Kingdom.
• No adverse health consequences are expected to result from this issue.

 Products Affected:

• There is only one product affected which is available from NHS Supply Chain’s eDirect Service

• Please note no other batch numbers are affected.

Next Steps:

• Read and follow the full instructions in the field safety notice and share with all users of the affected product. See our Downloads ▼ section.
• Locate and quarantine all affected product in your facility. The product code and lot number can be found on the individual product and shipping carton.
• Complete the enclosed Baxter Customer Reply Form, page two of the Field Safety Notice, and return it to Baxter using one of the following options:
• Scanning and emailing it to uk_shs_fca@baxter.com
• Faxing it to 01635 206034
• Please complete the Reply Form even if you do not have any inventory. Returning the customer reply form promptly will confirm receipt of this notification and prevent you receiving repeat notices. This step is required as per regulatory mandates.
• Contact your local NHS Supply Chain Customer Service Advisor with full details to enable us to monitor and manage any customer credit on your behalf as appropriate.
• This single lot recall should have no impact on future supplies of the product.

If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor.