Product Recall Laborie injeTAK Adjustable Tip Needles FUQ116 and FUQ117 (ICN 2067)

NHS Supply Chain Reference: 97

Alert:

• Laborie has issued a Field Safety Notice following a customer complaint involving a small hole found in the film of the sterile barrier of the injeTAK needle packaging (DIS201). Further investigation demonstrated that the issue was also present in product inventory (DIS199).
• A breach of sterile barrier carries the risk of infection.

Products Affected:

• The affected product codes are available from NHS Supply Chain:

• Please refer to table 1 and 2 found on page two of the Field Safety Notice for affected lot numbers.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Cease use and quarantine any affected batches.
• Contact your local NHS Supply Chain Customer Service Advisor with full details of affected products for return for full credit, using reason code 7 Supplier recall.
• All goods to be returned no later than Friday 21 April 2023.
• The supplier has confirmed that future orders will be fulfilled with unaffected product.
• If any adverse effects are experienced with the use of this product, please report it to Laborie Medical Technologies at customercareusa@laborie.com and your local regulatory agency or competent authority.

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