Recall Z-0471-2025 ยท FBK Endoscopic Injection Needle, Gastroenterology-Urology
Hobbs Medical, Inc.
Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4716
| Date | Nov 15, 2024 (initiated Oct 4, 2024) |
| Status | Open, Classified |
| Reason | Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle. |
| Root cause | Process change control |
| Action | On October 4, 2024 and October 8, 2024 consignees were sent URGENT MEDICAL DEVICE RECALL Actions requested on your part: 1. Read the Description of the problem section. 2. Immediately identify and set aside all product listed herein in a manner that ensures the affected product will not be used and will be returned to Hobbs Medical. 3. Review, complete, and return the enclosed Acknowledgement Form directly to Hobbs Medical Customer Service, return via Fax at 1-860-684-7574, or email to CustomerService@HobbsMedical.com. 4. Pass on this notice to anyone in your facility that needs to be inform |
| Quantity | 5 units |
| Distribution | Worldwide - US Nationwide distribution in the states of CT, GA, IN, MI, MN, MS, NH, NJ, NY, OH, TN, VT, WA, WI, WV and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K834403 | INJECTION NEEDLE Bobbs Medical, Inc., Feb 4, 1984 |