[Recalled] CORE¿ Suction Irrigation Handpiece without Probe for Single Solution Bags, Catalog Number CD8300 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other
A safety authority has issued a recall or warning for this item. The confirmed facts from the source notice are laid out below.
Recall details
| Product | CORE¿ Suction Irrigation Handpiece without Probe for Single Solution Bags, Catalog Number CD8300 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures. |
|---|---|
| Brand / manufacturer | ConMed Corporation |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0132-2017 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 27 June 2016 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: The packaging seal may contain a crease. The crease may result in an open channel. These channels may compromise sterility of the product.
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 ConMed Corporation
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.