FDA (Devices) recall action 93938
The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
Customer complaint received that reported the applier failed during surgery. The applier did not release the clip. The applier remained attached to the clip.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
A surgical clip applier from Peter Lazic Gmbh has been recalled after a reported failure to release the clip during surgery. The applier remained attached to the clip, potentially posing a safety risk during medical procedures.
Peter Lazic GmbH's D-Clip Standard/Mini Applier is being recalled after a customer complaint that the device failed to release the clip during surgery, with the applier remaining attached to the clip.
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.