Field Safety Corrective Action Filter A Line 96 Hour IV Filter (ICN 1847)
Important Customer Notice Field Safety Notice
Ref: 2022/1847 ICN Number: 1847
- Vygon has updated FSCA 2210/47526/00 to include an additional affected batch number.
- Product code 00080701 NPC FTC037 batch number 120222AH.
- Please check your inventory for the additional batch number and quarantine any affected product.
- Contact your local NHS supply Chain Customer Service Advisor with full details of the affected products. Your Advisor will arrange a return for full credit using reason code 7 Supplier Recall. All goods to returned no later than Friday 25 November 2022.
NHS Supply Chain Reference: 56
- The supplier Vygon has informed us that this recall has been initiated by the Legal Manufacturer of the filter component of product codes: 00080701 and 00080702. The Legal Manufacturer, PALL Corporation, has identified a defect on the outlet port of the filter.
- Use of this product may lead to clinical consequences, e.g. embolism. The root cause of the defect is currently under investigation.
- The affected products are available from NHS Supply Chain:
|NPC||Product Description||Supplier Code / MPC||Route|
|FTC037||Filter Endotoxin Intravenous with microbore tubing 0.22micron endotoxin retentive with injection port||00080701||Stocked|
|FTC065||Filter Endotoxin Intravenous with microbore tubing 0.22micron w/o injection port||00080702||Stocked|
- Please see our Downloads section to refer to the Field Safety Notice for full details of the affected batch numbers.
- Please note all current stock held by NHS Supply Chain has been checked and future deliveries will be of different, unaffected batch numbers.
- Read and follow the full instructions in the Field Corrective Notice and share with all users of the affected products.
- Cease use and quarantine all affected batch numbers.
- Contact your local NHS supply Chain Customer Service Advisor with full details of the affected products. Your advisor will arrange a return for full credit using reason code 7 Supplier Recall. All goods to be returned no later than Friday 25 November 2022.
If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor or Customer Relationship Manager..