Field Saftey Notice GB UK Healthcare Chest Drain Bottle (ICN 2026)
Important Customer Notice Field Safety Notice
- GB UK Healthcare has issued a Field Safety Notice following reports of cracks in the base of the chest drainage bottle CDB-001.
- The chest drainage system consists of a chest drainage bottle (1800ml capacity) and a tubing set.
- The tubing set is intended to allow the connection of the patient’s drainage catheter/s to the chest drainage bottle.
- The device is intended to be used on any patient requiring intrapleural drainage.
- The crack(s) could potentially allow the movement of air through it. Therefore, the device would not be a closed circuit.
- This may result:
- Air could be forced into the body, air and fluid may not be removed effectively from the chest cavity. This could significantly impact patient health and may be fatal if undetected.
- Leakage of biologically hazardous material from the bottle could occur. This could lead to cross contamination and infection to the patient and persons in the environment.
- The product code affected has been supplied on the Blue Diamond route by NHS Supply Chain:
|NPC||Product Description||Supplier Code / MPC||Route (or lot numbers)|
|FSW1437||Chest Drain Unit Bottle||CDB-001||22016414 22017952|
- Please note only the two Lot numbers listed are affected.
- The affected product codes are currently unavailable to order.
- GBUK anticipate full supply will not resume until May 2023.
- NHS Supply Chain is working with suppliers and this ICN will be updated as soon as further information is available.
- Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
- Where affected product codes or Lot numbers are identified, please contact your NHS Supply Chain Customer Service Advisor to arrange a return for full credit (reason code 7 Supplier Recall).
Please confirm if the quantity of product codes to be returned is a single or a pack of 10.
- All products are to be returned no later than 3 March 2023.
If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor.