[Recalled] Bard Monopty Disposable Core Biopsy Instruments and Kits, Monopty 14g x 16cm (22mm), Product Code: 121416; Monopty Biopsy, Product Code: 000441; Monopty 14g x 10cm (22mm), Product Code: 121410; Monopty 14g x 10cm (11mm), Product
The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.
Recall details
| Product | Bard Monopty Disposable Core Biopsy Instruments and Kits, Monopty 14g x 16cm (22mm), Product Code: 121416; Monopty Biopsy, Product Code: 000441; Monopty 14g x 10cm (22mm), Product Code: 121410; Monopty 14g x 10cm (11mm), Product Code: 211410. The BARD MONOPTY Disposable Core Biopsy Instrument is |
|---|---|
| Brand / manufacturer | Bard Peripheral Vascular Inc |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1447-2015 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 17 March 2015 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Bard Peripheral Vascular is recalling the Bard Monopty Disposable Core Biopsy Instruments and Kits because they may be at risk of having activation-related issues.
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 Bard Peripheral Vascular Inc
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.