Field Safety Notice ICU Medical MicroClave Clear Needle Free Connector Incomplete Assembly (ICN 1787)
Important Customer Notice Field Safety Notice
Ref: 2022/1787 ICN Number: 1787
NHS Supply Chain Reference: 40
- ICU Medical has issued an urgent Field Safety Notice following identification of a manufacturing defect with a specific Lot number of MicroClave Clear sets which may result in a visible gap between the connector’s top and bottom housings.
- Inadequate connection between the MicroClave Clear connector’s top and bottom housings may potentially cause fluid leak, blood loss, air ingress or contamination. To date, ICU Medical has not received any reports of serious injury or death associated with this issue.
- The affected product is available from NHS Supply Chain’s stock route:
|NCP||Product Description||Supplier Code / MPC||Lot Number|
|FSB1239||MicroClave Clear Needle Free Connector||011-MC100||5740706|
- Please note current stock has been checked and future order fulfilment will be of unaffected Lot numbers.
- Read and follow the full instructions in the Field Safety Notice and share with all users of the affected product.
- If product within the affected Lot is found, cease use, quarantine, and contact your local NHS Supply Chain Customer Service Advisor with full details of quantities held including whether full boxes (box 100) or part packs.
- Your Customer Service Advisor will confirm the details with you and provide a unique CMS reference number. On receipt of the completed certificate of destruction by email, quoting the CMS reference, full credit will be raised on your behalf.
If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor.