D-Clip Surgical Applier Recalled for Failure to Release During Surgery
FDA has recalled the D-Clip Standard/Mini Applier due to reports that the device failed to release the clip and remained attached during surgical use, creating a risk of surgical complications.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This Class II recall involves a surgical instrument that failed to function during actual use, creating risk of harm. However, the source reports no explicit hospitalization or injury outcomes, so it scores as High per the rubric for risk-of-harm products without reported injury.
Plain-English summary
The FDA is recalling the D-Clip Standard/Mini Applier (Model 35.412) manufactured by Peter Lazic Gmbh. This surgical instrument is designed to apply D-clips during medical procedures.
A customer complaint reported that the applier malfunctioned during surgery. The device failed to release the clip as intended and remained attached to the clip following the procedure.
The recalled devices are identified by Model 35.412 and UDI/DI 04250603739616 and include all lot numbers. Distribution was nationwide in Maine.
Users should discontinue use of the affected appliers and contact Peter Lazic Gmbh or their medical supplier for replacement or return instructions. Any adverse events associated with this product should be reported to the FDA.
The recalled product
- Product
- D-Clip Standard/Mini Applier, 230mm bayonet, jaw rigid, double action.
- Manufacturer
- Peter Lazic Gmbh
- Hazard
- device-failure
- release-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model number: 35.412
- UDI/DI: 04250603739616
- All Lot numbers.
Distribution
Distributed nationwide across the United States.
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