Avanos Medical Limited Digestive Health and Acute Pain Portfolio (ICN 1360)

Important Customer Notice Field Safety Notice

Ref: 2021/1360 ICN Number: 1360

Recall Ref: NHSSC 45A

Alert:

  • Avanos Medical (formerly Halyard Health) is issuing a further Field Safety Notice (FSN) for the devices listed in Annex 1 in the FSN after they became aware that some further products had been shipped without the Instructions For Use (IFU) included in the packaging. (see our Downloads ▼ section.)
  • Instructions For Use are an integral part of the device and may need to be consulted for appropriate usage of the devices.
  • There is no immediate hazard for the patient, as the devices have an established clinical use and can be safely used by healthcare professionals without the IFU if they are comfortable doing so.
  • If there is a need to consult the IFU, there is a link and QR code on the packaging that indicates the location of an electronic version of the IFU.

Products Affected:
There are three additional NHS Supply Chain Products affected and an additional Lot on a product included in the previous FSN. These are all supplied via our Blue Diamond route.

NPC Product Description Supplier Code/ MPC Affected Lot Number Supply Route
FSB2368 Disposable infusion pump Soaker 12.5cm Expansion Kit 101353402
PM020
20050929 Blue Diamond
FWM3233 Feeding Tube Gastrostomy Balloon Retained 12fg MIC Gastrostomy Feeding Tube ENFit 104450001
8100-12LV
30124236 Blue Diamond
FSB2518 Disposable infusion pump ON-Q Soaker 12.5cm Expansion Kit NRFith 104516201
PM020-N
30109015 Blue Diamond

Next Steps:

  • Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
  • If you need to consult the Instructions For Use an electronic copy can be found by using the QR code or weblink included in the FSN.

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

Recall Ref: NHSSC 45

Alert:  

  • Avanos Medical (formerly Halyard Health) is issuing a Field Safety Notice (FSN) for the devices listed in Annex 1 in each of the two FSNs (see our Downloads ▼ section.) after they became aware that some products had been shipped without the Instructions For Use (IFU) included in the packaging.
  • Instructions For Use are an integral part of the device and may need to be consulted for appropriate usage of the devices.
  • There is no immediate hazard for the patient, as the devices have an established clinical use and can be safely used by healthcare professionals without the IFU if they are comfortable doing so.
  • If there is a need to consult the IFU, there is a link and QR code on the packaging that indicates the location of an electronic version of the IFU.

Products Affected:

  • There are four NHS Supply Chain Products affected. Three are via our Blue Diamond route and one is stocked in our network.
NPC Product Description Supplier Code/ MPC Affected Lot Number Supply Route
FWM3239 Feeding Tube Gastrostomy Balloon Retained 22fg MIC Bolus Gastrostomy Tube ENFit 1044564018110-22 20021689 Blue Diamond
FWM2351 Feeding Tube Nasojejunal 12fg 152cm polyurethane radiopaque regular centimeter markings unweighted 300cm 0.035 teflon coated flexible guidewire in dispenser sheath 10fgx56cm Nasal/ORAL TRANSFER TUBE WITH ENFit connectors 10462300251-4602-22 30111646 Stocked
FWM3236 Feeding Tube Gastrostomy Balloon Retained 16fg MIC Bolus Gastrostomy Tube ENFit 1044561018110-16LV 20060513 Blue Diamond
FSB2397 Disposable infusion pump ON-Q System and Soaker 2.5cm 100ml x 2ml/h 101343302PS2502 30058339 Blue Diamond
  • Please note no other batch numbers are affected.
  • Current stock in our warehouses of FWM2351 has been checked and all affected Lots found have been quarantined.

Next Steps:

  • Read and follow the full instructions in the attached two Field Safety Notice and share with all users of the affected products.
  • Where affected product/ lot numbers are identified, then return the completed Annex 1 in the Word Document version of the FSN via email to EMEAFieldAction@avanos.com within five (5) business days of receipt of this notification.
  • Avanos Medical will replace the products free of charge.

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

Downloads ▼

  • 1360 Avanos Customer Return Form

    A PDF document of the Customer Return Form for ICN 1360.
  • 1360 Avanos Field Safety Notice Normanton

    A PDF of the Field Safety Notice for Normanton customers for ICN 1360.
  • 1360 Avanos Field Safety Notice Rugby

    A PDF of the Field Safety Notice for Rugby customers for ICN 1360.
  • 1360 Update to the Field Safety Notice for Normanton

    A PDF letter of the updated Field Safety Notice for Normanton customers for ICN 1360.