Z-1848-2020 Class I Terminated
FDA device recall Z-1848-2020 was initiated by Applied Medical Resources Corp on October 24, 2019 and is designated Class I. Reason for recall: 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. The recall status is terminated (terminated June 1, 2023). Affected quantity: 28,799 catheters in total.
Recall Details
- Product Type
- Devices
- Report Date
- May 13, 2020
- Initiation Date
- October 24, 2019
- Termination Date
- June 1, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 28,799 catheters in total
Product Description
Applied Medical Dual Lumen Graft Cleaning Catheter & 1cc SYRINGE Nonpyrogenic, REF: A4GW6, 5F X 60cm, 9mm, Sterile EO, CE, UDI: (01)00607915111175
Reason for Recall
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.
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
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