Field Safety Notice: Important information for distributors and end-users of Convatec Esteem Body drainable large pouches

The British Healthcare Trades Association (BHTA) has become aware of a Field Safety Notice issued by Convatec, which is a BHTA member, regarding specific lots of its Esteem Body drainable large pouches.

Convatec has initiated a voluntary Field Safety Corrective Action (product removal) following the identification of a manufacturing variation affecting the drainable tail section of certain pouches. The variation may result in leakage from the tail closure.

Distributors and end-users (healthcare facilities or direct customers) should review this notice carefully. It outlines the affected product codes and lot numbers, explains the nature of the identified issue, details the actions already taken by Convatec, and sets out the specific steps that distributors and end-users are required to follow.

Full details of the manufacturer’s Field Safety Notice can be viewed here.

Products and lots affected

The Field Safety Notice applies to specific UK product codes and lot numbers of Esteem Body drainable large pouches distributed within the timeframe outlined in the manufacturer’s notice.

Distributors and end-users are advised to refer to the official Field Safety Notice for the full list of affected product codes, the specific lot numbers involved, and the relevant distribution period. Only the lots identified in the notice are affected.

Nature of the issue

Convatec has completed an internal health hazard evaluation, which determined that the identified manufacturing variation may result in minor skin irritation in a limited number of users. The potential severity is considered low, according to Convatec, and no adverse events have been reported to date.

Action taken by Convatec

Convatec has confirmed that shipment of affected product has been stopped, and all remaining stock has been quarantined. Corrective and preventive measures are underway to prevent a reoccurrence, a voluntary Field Action across the impacted countries has been initiated, and all relevant regulatory authorities have been notified in accordance with applicable requirements.

Actions required by distributors

Distributors of the affected product should:

• Review inventory immediately to identify any affected product codes and lot numbers
• Quarantine any impacted stock
• Inform any downstream customers who may have received an affected product
• Complete and return the response documentation as outlined in the Field Safety Notice
• Arrange for destruction and credit in accordance with Convatec’s instructions

All required steps and timelines are detailed in the official notice.

Actions required by end-users (healthcare facilities/direct customers)

End-users and healthcare facilities, or direct customers, who may have the affected product should:

• Check product packaging for the listed product codes and lot numbers
• Follow the guidance provided in the Field Safety Notice regarding continued use or disposal
• Complete and return the response form where requested
• Report any issues in line with the manufacturer’s instructions

End-users with questions should contact Convatec Customer Services using the contact details provided in the Field Safety Notice.

Further information

This communication is issued to ensure that BHTA members, distributors, and end-users are aware of the manufacturer’s Field Safety Corrective Action and the steps required.

If you are a distributor or end-user of the affected Esteem Body drainable large pouches, please review the notice carefully, and take the appropriate action without delay.