[Recalled] Clip Applier Kit, REF: K2887, UDI: (01)30607915139132(17)220822(30)1(10) — There may be a slightly protruding rivet on the distal end of the laparoscopic… | FDA 2020-03-17
The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.
Recall details
| Product | Clip Applier Kit, REF: K2887, UDI: (01)30607915139132(17)220822(30)1(10) |
|---|---|
| Brand / manufacturer | Applied Medical Resources Corp |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-2161-2020 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 17 March 2020 |
| EAN / barcode | 30607915139132 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: There may be a slightly protruding rivet on the distal end of the laparoscopic grasper which has the potential for tissue to catch on it during use and lead to tissue damage.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Applied Medical Resources Corp
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.