[Recalled] Python Embolectomy Catheters, Sterile EO, CE, Ref numbers/UDI: A4E01/(01)00607915113407; A4E02/(01)00607915113414; A4E03/(01)00607915113421; A4E04/(01)00607915113438; A4E05/(01)00607915113445; A4E06/(01)00607915113452; A4E0
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 | Python Embolectomy Catheters, Sterile EO, CE, Ref numbers/UDI: A4E01/(01)00607915113407; A4E02/(01)00607915113414; A4E03/(01)00607915113421; A4E04/(01)00607915113438; A4E05/(01)00607915113445; A4E06/(01)00607915113452; A4E08/(01)00607915113476; A4E09/(01)00607915113483 |
|---|---|
| Brand / manufacturer | Applied Medical Resources Corp |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1846-2020 |
| Country of notice | United States |
| Risk level | Class I |
| Hazard type | recall |
| Notice date | 24 October 2019 |
| EAN / barcode | 00607915113407 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: The firm has received reports of tip separation during usage of the catheters, which may expose patients to unintended dislodgement of the tip from the body of the catheter.
This Class I 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
Stop using the product immediately and follow the authority's remedy (return, repair, or disposal).
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.