Field Safety Notice Pennine Healthcare Suction Connecting Tubes and Link Yankauer Sets (ICN 2006)
Important Customer Notice Field Safety Notice
Ref: 2023/2006
ICN Number: 2006
Alert:
- The supplier Pennine Healthcare has issued an Urgent Field Safety Notice following receipt of two customer complaints related to sterile barrier (pouch) breach.
- The pouches were found to be open before use, potentially compromising product sterility.
- Using a non-sterile device may increase the risk of patient infection.
- As the issue was identified prior to use no patient harm has been reported.
Products Affected:
- Affected batches of two NHS Supply Chain products may have been supplied:
NPC | Product Description | Supplier Code / MPC | Route |
FDB118 | Tube Yankauer Suction Maxitip Vacuum Control 3M | LYS-5731 | Stock |
FDH933 | Tube Yankauer Suction 6mm x 3m | LYS-5531 | eDirect |
- Please note only the batch numbers listed in the Field Safety Notice are affected.
- Pennine Healthcare confirm this recall will not impact on future supplies.
Next Steps:
- Read and follow the full instructions in the Field Corrective 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 including NPC, lot numbers and quantity stating whether boxes or eaches.
- Your Customer Service Advisor will give you a unique CMS log number and on receipt of written confirmation, email quoting the CMS reference, of disposal in accordance with your local regulations will raise the appropriate credit.
- All notification of affected batches must be made by Friday 10 February 2023.
If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor or Customer Relationship Manager.