Field Safety Notice GBUK Banana Patient Clip Slings (ICN 2408)

• GBUK has requested an additional email address be used for the return of the completed FSCA Acknowledgement form, please send these to Melonie Clark: melonie.clark@gbukgroup.com and also to Emily Kay: emily.kay@gbukgroup.com

Alert:

• Following several complaints of incorrect assembly of the keyhole clasp, leading to the clips which secure the sling to the hoist facing in the wrong direction, GBUK Banana has initiated a voluntary Product Recall for the specific Lot numbers of the affected slings.
• This issue could result in the clips not clicking securely into place and securing the sling to the hoist during use. If the clips are not securely attached there is a risk of the patient falling from the sling and sustaining injury.
• GBUK advise there have been no reported injuries associated with this product fault and anticipate only a low percentage of slings are affected.

Products Affected:

• These products are available on the eDirect route from NHS Supply Chain. Please refer to the attached product listing and Field Safety Notice for full details and affected Lot numbers.
• Please note only the Lot numbers quoted are affected.
  

  NPC	Product Description	Supplier Code / MPC	Lot numbers
  FER14254	Clip High Back Sling Single Patient Use Medium	B-SSPUC-M	230215 230715 230615 230730
  FER14255	Clip High Back Sling Single Patient Use X-Large	B-SSPUC-XL	230615 230715
  FER14257	Clip High Back Sling Single Patient Use Small	B-SSPUC-S	230615 230215 230715
  FER14258	Clip High Back Sling Single Patient Use Large	B-SSPUC-L	230615 230215
  FER14259	Clip High Back Sling Single Patient Use X-Small	B-SSPUC-XS	230615

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 all affected Lot numbers.
• Complete the FSCA Acknowledgement form and return to Melonie Clark, Quality Manager, GBUK by email to: melonie.clark@gbukgroup.com
• On receipt of the completed acknowledgement form GBUK will arrange collection and replacement of the affected Lot numbers in your possession.
• Where affected product/Lot numbers are identified, please also contact your NHS Supply Chain Customer Service Advisor with full details, to enable us to assist you in the event you require credit rather than replacement.
• Where potential alternatives are identified, customers are advised to consult your own clinical experts to ensure suitability for your organisations use of these products.

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

Please be aware that in the event of a Field Safety Notice/Product Recall we may need to provide manufacturers, UK responsible Persons and Distributers with contact details of customers who have potentially received the affected stock. This is to help them to reconcile their stock and evidence to the regulators that all actions have been taken to ensure that the unused products have been removed from customers to prevent inadvertent use of faulty and potentially unsafe products.