Pennine Healthcare Tubes PHFSN0219 (ICN 691)

Important Customer Notice Update

Ref: 2019/691 ICN Number: 691
  • Following a recall of Ryles and Levins tubes from Pennine Healthcare, the manufacturer is producing new stock.
  • This updated ICN is to provide customers with the latest information provided by Pennine Healthcare and its plans to rationalise this range of products, in order to concentrate production on fewer products to speed up production.
  • All previous supply issues mentioned in our last ICN update have been resolved.
  • A total of 27 product codes are currently unavailable to order and will be delisted from our online catalogue.
  • Customers are advised to log in to our website to view the indirect alternative products where available.
  • Please see our Downloads ▼ section to view the affected product codes.
    • Following a recall of Ryles and Levins tubes from Pennine Healthcare, the manufacturer is producing new stock.
    • This updated ICN is to provide customers with the latest information provided by Pennine Healthcare and its plans to rationalise this range of products, in order to concentrate production on fewer products to speed up production and resolve the supply issues.
    • 13 product codes are now available but are affected by a temporary supply issue with intermittent supply only.
    • 15 product codes will be delisted and replaced by a new and improved range next year.
    • Four of the affected delisted codes are still available whilst stocks last but will be unavailable once stock has been depleted.
    • The four product codes are:
      FWN810 – Ryles Tube 10fg x 122cm with 1cm graduations 4 side eyes xray tip and closed end.
      FWN820 – Ryles Tube 14fg x 122cm with 1cm graduations 4 side eyes xray tip and closed end.
      FWN825 – Ryles Tube 16fg x 122cm with 1cm graduations 4 side eyes xray tip and closed end.
      FWN830 – Ryles Tube 18fg x 122cm with 1cm graduations 4 side eyes xray tip and closed end.
    • Customers are advised to log in to our website to view the indirect alternative products.
    • The other 11 products to be delisted are currently suspended as part the recall.
    • Due to the limited alternative options currently available on this framework, we expect continued supply issues and recommend customers to contact Karen Hudson, the Clinical Programme Manager for NHS Supply Chain: Ward Based Consumables, Infection Control and Wound Care for suitability of other alternatives until this is fully resolved.

Karen Hudson

Clinical Programme Manager

  • The anticipated resolution date is expected to be by March 2020.
  • Please See our Downloads ▼ section to view the affected product codes.
  • The supplier Pennine Healthcare has informed us all Pennine Healthcare products affected by the recall are expected to be available as normal by mid-November. A further update will be published when all products are available.
  • If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor.
  • The supplier Pennine Healthcare has undertaken a physical stock check on NHS Supply Chain premises of the 12 products stocked and has confirmed all NHS Supply Chain stock has passed an initial check.
  • Clinicians should still continue to check products before use, as part of a secondary check, and follow the necessary returns procedure if required.
  • There are 16 non-stocked products which have not yet been checked and therefore customers are advised that the recall and recommended actions set out in the Field Safety Notice are still in effect.
  • For full detail of affected Pennine Healthcare products please refer to the updated listing in our download section.
  • All Pennine Healthcare products affected by the recall are expected to be available as normal by mid-September. A further update will be published.

Recall Ref 14

  • Pennine Healthcare have advised that there are now 28 product codes affected across various lot numbers.
  • Please see below, a revised product list of the affected codes for the Pennine Field Safety Notice, with alternative product codes added.
  • Customers are advised that due to the market share held by Pennine Healthcare, the alternative product codes listed may also be affected.
  • There are further feeding and drainage tubes available on the Enteral Feeding Framework.
  • Please contact Christopher Brown Christopher.Brown8@supplychain.nhs.uk in our clinical Consultation Team to discuss your requirements and the suitability of additional products in the catalogue.

Alert:

  • Pennine Healthcare has issued an urgent Field Safety Notice affecting specific lot numbers for a range of their catheters, tubes and medical packs.
  • This is following postproduction activities identifying the potential that these products may not have been manufactured with the correct eyes, (holes) punched in the tubes.

Products Affected:

  • There are 29 NHS Supply Chain product codes affected across various lot numbers.
  • Currently there are no suitable alternative products available to order through our online catalogue.
  • See our Downloads ▼ section below for information on the affected product codes and to the Field Safety Notice for information on the affected lot numbers.

Next Steps:

  • Read and follow the full instructions in the Field Safety Notice and share this document with all users of the affected products.
  • Identify and quarantine all stock of the affected bath or LOT number immediately.
  • Complete the attached Reply Form (addendum B) to confirm you have read and understood this Field Safety Notice, and return to recalls@penninehealthcare.co.uk
  • Contact your NHS Supply Chain Customer Service Advisor to arrange return of all unused products for full credit, using reason code 7 “Supplier Recall”.
  • All products are to be returned no later than Friday 7 June 2019.
  • Suitable alternative products are being sourced and we will update this ICN when they are available.

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

Downloads ▼

  • 691 Pennine Healthcare Product Listing

    An Excel spreadsheet showing product listing for this ICN.

    Please to view this content.

  • 691 Pennine Healthcare Urgent Field Safety Notice

    A PDF document detailing the Field Safety Notice for ICN 691.
  • 691 Pennine Healthcare Delisted Products

    An Excel file detailing the delisted products for ICN 691.

    Please to view this content.