Class 2 Device Recall PosiStop Injection Needle

• Date Initiated by Firm: October 04, 2024
• Date Posted: November 15, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0469-2025
• Recall Event ID: 95577
• 510(K)Number: K834403
• Product Classification: endoscopic injection needle, gastroenterology-urology - Product Code FBK
• Product: Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4702
• Code Information: Catalog Number: 4702; UDI-DI: M84947020; Lot Numbers: H08-23-263, H01-24-114.
• Recalling Firm/ Manufacturer: Hobbs Medical, Inc.; 8 Spring St; Stafford Springs CT 06076-1505
• For Additional Information Contact: Customer Service; 800-344-6227
• Manufacturer Reason for Recall: 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.
• FDA Determined 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 informed according to your internal notification procedures. 5. If any product listed below has been forwarded to another facility, contact that facility to arrange return. 6. Maintain awareness of this notice until all product listed above has been returned to Hobbs Medical. The following assistance is available: " For questions related to the issue or product replacement, please contact Hobbs Medical Customer Service. " For questions related to product return please contact Hobbs Medical Customer Service Return instructions are provided on the Acknowledgement Form. " For questions related to the Acknowledgement Form and its return, please contact Hobbs Customer Service at 1-800-344-6227. In addition to standard complaint notification to Hobbs Medical, any adverse events experienced with the use of this product and/or quality problems should also be reported to the FDA s MedWatch Program by fax at 1-800-332-0178; by mail at MedWatch, FDA, 5600 Fischers Lane, Rockville, MD 20857; or on the MedWatch website at www.fda.gov/medwatch We apologize for any inconvenience this communication may cause. We know that you place high value in our products and we appreciate your cooperation in this matter. Hobbs Medical is committed to maintaining your confidence in the safety and quality of the products that Hobbs Medical supplies.
• Quantity in Commerce: 45 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = FBK