Avanos Medical UK limited (Halyard Health) Closed Suction System

Important Customer Notice Recall

Ref: 2020/949 ICN Number: 949

Ref: MHRA 2019/011/015/291/004
Recall Ref: 74

Alert:

  • Avanos Medical UK limited (Halyard Health) has issued a Field Safety Notice for three lots of their Closed Suction System 195-5.
  • The identified lots have an increased likelihood (up to approximately 0.075%) for full occlusion.

Products Affected:

  • The affected product is available from NHS Supply Chain as:
    NPC MPC Item Description Lot Number
    FSQ300 195-5 Catheter closed suction system neonatal/paediatric 5 Fr 30.5cm with Y endotracheal adaptors. M18268T402 M18274T402 M18290T402

Next Steps:

  • Read and follow the full instructions in the Field Safety Notice with particular attention to the instructions below and share with all users of the affected products.

 

Additional actions to mitigate risk associated with all 5 Fr Closed Suction Catheters.

All other lots of 5 Fr CSCs are not directly associated with total occlusions but have a risk for partial occlusion. As a safety precaution, customers should always confirm that CSC products can adequately suction before use on a patient.

Testing the ability of the catheter to suction prior to use can be conducted by first connecting the CSCs proximal adapter to wall suction or to a suction unit. Advance the suction catheter, so the distal tip protrudes from the distal connector. Activate suction by depressing the thumb valve and occlude the distal tip openings with a sterile glove to demonstrate an increase in the suctioning negative pressure, OR place distal tip into sterile water or saline to verify ability to suction fluid.

If the CSC appears occluded, users should not use and immediately replace the product. Always inform Avanos Medical (Halyard) if such a situation comes to your attention.

As this mitigation is considered a general safety precaution for this product in the intended patient population, the Instructions for Use (IFU) will be updated to reflect this warning.

In addition, the current IFU reminds clinicians to note any signs of suction intolerance during use which include oxygen desaturation, negative ventilator system pressures, patient stress, or excessive discomfort. Clinicians should also note that a differential diagnosis on the reason for the suction intolerance may be difficult with this issue, as these signs may also result from neonates not tolerating the therapy due to reasons other than occlusion.

Please refer also to the instructions for use to ensure adequate suction performance of the CSCs during its use and ensure that: CSC are appropriately irrigated after every use – CSC are replaced at least every 24hrs.

  • Complete and return the acknowledgment form (within the Field Safety Notice) to EMEAFieldAction@avanos.com.
  • If affected product is identified, please contact your NHS Supply Chain Customer Service Advisor who can arrange a return for full credit (reason code 7). All products to be returned no later than 14 February 2020.

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

Downloads ▼

  • 949 Avanos Closed Suction System Field Safety Notice

    A PDF document detailing the field safety notice for ICN 949.