GBUK 1ml enteral syringe (ICN 944)
Important Customer Notice Field Safety Notice
MRHA Ref : 2020/001/014/487/010
Recall Ref 72
- GBUK has issued a Field Safety Notice voluntarily, recalling a specific batch of its 1ml enteral syringe ELDISO-1.
- GBUK has been made aware of a manufacturing error related to the product code identified above. The error concerns the graduation markings on the barrel of the syringes. Specifically, the major graduation marking at 0,5ml is incorrectly placed potentially resulting in an inaccurate dose delivery of medication equating to 0.01ml.
- GBUK considers that since this affects a major graduation, the error in delivery of the medication dosage by a health care professional could occur and therefore the decision has been made to recall this batch of affected devices.
- GBUK 1ml enteral syringe available via NHS Supply Chain as NPC FWM2427 MPC ELDISO-1.
- Lot/batch number 2601119291 only.
- The affected batch has been removed from sale, unaffected batches of this product are still available for purchase.
- Potential indirect alternative products are available to order through our online catalogue.
- See our Downloads ▼ section to view the product listing for further information on the affected product code.
- Read and follow the full instructions in the Field Safety Notice and share this document with all users of the affected products.
- Please complete the acknowledgment form and email it to firstname.lastname@example.org. This form must be returned even if you do not have any of the affected product.
- Where the affected lot number 2601119291 is found please contact your NHS Supply Chain Customer Service Advisor with full details to arrange return for full credit using reason code 7 “Supplier Recall”.
- All products to be returned no later than Friday 7 February 2020.
If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor.
- A potential safety concern regarding a single batch of GBUK 1ml enteral syringe has been identified.
- GBUK 1ml enteral syringe available via NHS Supply Chain as NPC FWM2427 – Lot/batch number 2601119291 only.
- This line is temporarily being quarantined pending further investigation, we recommend that all customers please quarantine all stock until further notice.
- Further information on how to proceed will be issued in a follow up ICN.
- An alternative product has been identified, product code FTA326 Enteral Feeding syringe 1ml purple low dose – ENFIT connector from the supplier Medicina Limited.