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.

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.