Advice
Regulatory information
Regulatory information
Histoacryl is a CE marked class III medical device regulated under the Medical Devices Directive (1993/42/EC) Annex II (4). The Histoacryl LapFix Pack is a procedure pack in accordance with MDR 2017/745/EEC art. 22, which has no direct risk class assigned. The applicator that is provided with Histoacryl LapFix Pack is the only applicator that is recommended for use with Histoacryl glue. The applicator is a CE marked class IIa medical device. The company intends to renew regulatory approval to allow ongoing availability in the UK beyond June 2023.
LiquiBand Fix8 is a CE marked class IIb medical device. Both LiquiBand Fix8 (open and laparoscopic) devices are approved for use in the UK under Medical Device Regulations effective March 2022 to March 2025. The glue is preloaded and not available as a separate product.
Glubran2 is a CE marked class III medical device. The Glutack applicator (and Glutack Short) is a CE marked class IIa medical device. The devices have been registered to the Medicines and Healthcare products Regulatory Agency (MHRA) by a UK Responsible Person for GEM, and UKCA (UK Conformity Assessed) mark preparation is in progress.
The following company field safety notices for these technologies have been identified:
In February 2022, Advanced Medical Solutions recalled LiquiBand Fix8 open devices to instigate a number of design changes to overcome a mechanical defect which had caused uncontrolled leakage of glue from the distal tip of the device (update to field safety notice: 01-31-2022-001-FSCA). The company hopes to return the product to market from 30 June 2022.
In April 2021, B Braun Surgical recalled some batches of Histoacryl in which incomplete polymerisation had led to reduced adhesive forces (MHRA reference: 2021/003/009/601/001). The clinical risk was considered acceptable with no risk to patients except a possible operating time extension if an alternative fixation method was needed. The company has advised that the incident has now been resolved and availability of all Histoacryl products is back to normal levels.