Cardinal Health PROTEXIS™ Latex Micro Surgical Gloves (ICN 1098)

Important Customer Notice Field Safety Notice

Ref: 2020/1098 ICN Number: 1098

NHSSC: 35A

Update:     

  • Cardinal Health has issued a further Field Safety Notice (Correction) to their Field Safety Notice dated 29 July 2020, for additional lots of PROTEXIS™ Latex Micro Surgical Gloves.
  • Affected lots may have possible holes and donning tears at the folding area around the cuffs.
  • There is a potential risk of infection or cross-patient (clinician) exposure to body fluids. Cardinal Health is not aware of any reports of patient harm.

Products Affected:

  • There are eight affected products available via NHS Supply Chain’s stock and eDirect route.
  • Please see our Downloads ▼ section to refer to the Field Safety Notice and product listing for further information on the affected product codes.
  • Please note only the batch numbers listed in the Field Safety Notice are affected.

Next Steps: 

  • Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
  • Given the demand for personal protective equipment (PPE) during the current COVID-19 global health crisis, Cardinal Health is asking customers to implement the actions described below.
  • Inspect the entire surgical glove for any holes or tears after donning has occurred.
    If a hole or tear is detected, the glove must be discarded, and a new glove must be obtained. Inspect the new glove for holes or tears in the same manner.
    Double-gloving is recommended to provide additional barrier protection.
  • Cardinal has assured us there should be no impact on future supplies of these gloves.
  • Complete the Customer acknowledgement form and email to: GMB-CASHEL-RA@cardinalhealth.com

MHRA 2020/007/028/701/046
NHSSC: 35

Alert:

  • This recall is being conducted due to a degradation defect that was found on Cardinal Health™ PROTEXIS™ Latex Micro Surgical Gloves that could lead to holes and donning tears at the folding area around the cuffs (See our Downloads ▼ section and refer to exhibit B in the Field Safety Notice for examples of the defect).
  • There is a potential risk of infection or cross-patient (clinician) exposure to body fluids. Cardinal Health is not aware of any reports of patient harm.
  • Cardinal Health is voluntarily taking this action.

Products Affected:

  • There are eight affected products available via NHS Supply Chain’s stock and eDirect route.
  • See our Downloads ▼ section to view the Field Safety Notice and product listing for further information on the affected product codes.
  • Please note only the batch numbers listed in the Field Safety Notice are affected.

Next Steps:

  • Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
  • Where affected product/ lot numbers are identified, customers are to remove from use and dispose of any affected product according to their trusts disposal procedures.
  • Contact your local NHS Supply Chain Customer Service Advisor, who will manage the credit on your behalf.
  • Cardinal Health has assured us there should be no impact on future supplies of these gloves.
  • Complete the customer acknowledgement form and email to: GMB-CASHEL-RA@cardinalhealth.com.

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

Downloads ▼

  • 1098 Cardinal Health Product Listing

    An Excel file detailing the affected product codes for ICN 1098.
  • 1098 Cardinal Health Appendix A

    A PDF of the Appendix A for ICN 1098.
  • 1098 Cardinal Health Customer Response Form

    A PDF of the Customer Response Form for ICN 1098.
  • 1098 Cardinal Health Field Safety Notice

    A PDF document of the Field Safety Notice for ICN 1098.
  • 1098 Cardinal Health Customer Response Form Update

    A PDF of the updated Customer Response Form for ICN 1098.
  • 1098 Cardinal Health Field Safety Notice Update

    A PDF of the updated Field Safety Notice for ICN 1098.
  • 1098 Cardinal Health Product Listing Update

    An Excel file detailing the updated affected product codes for ICN 1098.

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