Device product
Applied Medical Dual Lumen Graft Cleaning Catheter & 1cc SYRINGE Nonpyrogenic, REF: A4GW6, 5F X 60cm, 9mm, Sterile EO, CE, UDI: (01)00607915111175
Z-1848-2020
Product summary
- Event
- Event 85057
- Status
- Terminated
- Classification
- Class I
- Quantity
- 28,799 catheters in total
- Official record key
device-enforcement:Z-1848-2020
Official wording
Reason: 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.
Code information: Model A4GW6, Applied Medical DUAL LUMEN GRAFT CLEANING CATETER, 9mm X 60cm, lot numbers 1267676, 1272322, 1284680, 1295323, 1306127, 1312586, 1330450, 1334826, 1338738, 1339555
Distribution pattern: Worldwide distribution - United States: Nationwide OUS: Australia, Belgium, Canada, Czech Republic, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Netherlands, Poland, Saudi Arabia, South Africa, Spain, Taiwan, United Kingdom
Derived failure modes
-
Unknown
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.