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The British Healthcare Trades Association (BHTA) is aware of a Field Safety Notice issued by BHTA member company Invacare concerning certain Invacare Robin chargers used with Invacare Robin ceiling hoists.
This article shares important safety information for providers and users of the Invacare Robin hoist who may have received affected chargers.
Invacare has identified that a limited quantity of Invacare Robin chargers, delivered as spare parts, were fitted with an incorrect fuse. As a result, the charger no longer meets the minimum IPX4 ingress protection rating required under ISO 10535.
The Invacare Robin charger is used to charge the Invacare Robin ceiling hoist, which is designed to transfer and position completely or partially immobile patients within compatible track systems.
According to Invacare, the issue was identified following a complaint relating to Robin chargers. Although no incidents or injuries have been reported, the manufacturer has advised that, in a worst-case scenario, the issue could lead to serious injury or death.
Invacare has advised that the compromised IP rating may create a safety risk in certain circumstances.
While no adverse events have occurred, the manufacturer considers the probability of occurrence to be significant enough to require the recall of affected chargers.
The issue affects only certain chargers supplied as spare parts and not all Invacare Robin systems.
The Field Safety Notice applies to specific Invacare Robin charger sets with UK plugs supplied as spare parts.
Affected product details:
Invacare has provided images within the Field Safety Notice to help users identify affected chargers. Chargers marked “N/OK” in the notice are subject to the recall.
Invacare UK is contacting affected providers directly in line with the identified charger range.
Providers and users who believe they may have received an affected charger should:
Invacare UK will arrange transport for the collection of affected chargers once the relevant documentation has been completed.
Invacare has confirmed that all returned chargers will be replaced with new compliant chargers.
The manufacturer will record confirmation of all corrective actions undertaken as part of the recall process.
Providers and users are encouraged to review the Field Safety Notice for full details and identification guidance.
For further information or assistance relating to this Field Safety Notice, please contact Invacare UK Technical Services:
This communication is intended to ensure that providers and users of the Invacare Robin hoist are aware of the manufacturer’s corrective action and the steps required to support continued patient safety and compliance.
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.
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.
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.
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.
Distributors of the affected product should:
All required steps and timelines are detailed in the official notice.
End-users and healthcare facilities, or direct customers, who may have the affected product should:
End-users with questions should contact Convatec Customer Services using the contact details provided in the Field Safety Notice.
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.