Official recall record
30 atm MONARCH® Inflation Syringe
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2024-09-09
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
On July 31, 2024, Merit internally identified an issue related to potential holes being found in the Tyvek® sterile barrier of certain MONARCH® inflation devices during the manufacture of lot H3003824. Visual inspection of the packaged units from lot H3003824 found a potential hole in 28 of 776 manufactured units. The 28 units underwent a bubble test where 23 of the 28 units failed, confirming a hole in the sterile barrier. Further investigation has determined that certain placements of the MONARCH® inflation device within a rigid formed blister tray can cause a hole in the Tyvek®. Should a MONARCH® inflation device's placement result in the unit's retainer cap being positioned above the rigid blister flange, the Tyvek® can contact a multivac's cross-cut station potentially leading to an abrasion or hole in the Tyvek®. Recall start date: August 28, 2024
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Record last checked against the registry on 2026-05-31.