Class 2 Device Recall Remington MEDICAL Automatic Cutting Needle

• Date Initiated by Firm: December 02, 2022
• Date Posted: December 28, 2022
• Recall Status: Completed
• Recall Number: Z-0771-2023
• Recall Event ID: 91275
• 510(K)Number: K191315
• Product Classification: Instrument, biopsy - Product Code KNW
• Product: Remington MEDICAL, Automatic Cutting Needle, 18ga (1.3mm) x 20cm, REF NAC-1820M (1)
• Code Information: UDI/DI 00813079020936, Lot Number 2224920, exp. 2025-09/06
• Recalling Firm/ Manufacturer: Remington Medical, Inc.; 6830 Meadowridge Ct; Alpharetta GA 30005-2202
• For Additional Information Contact: C. Matt Brown; 470-719-1121
• Manufacturer Reason for Recall: The stylet is longer than specified on the label
• FDA Determined Cause: Under Investigation by firm
• Action: The firm issued an URGENT: RECALL NOTIFICATION LETTER to its consignees on 12/02/2022 by email. The notice requested the following: "Actions to be Taken: The following steps are to be taken by all impacted customers: 1. Please be aware that this issue may be present in your company s inventory (refer to the impacted lot number listed below). Please communicate the possibility of this issue to all parties in your facility who may be impacted so that they are aware of the potential risks associated with this product and so replacement products may be obtained, if necessary. 2. Complete the enclosed Notice Reply Form and fax it to the attention of RMI s QA Recall Coordinator, at 770-888-8524 or scan the completed form and e-mail to quality@remmed.com. The form lists the catalog number(s) and lot number(s) of impacted product our records indicate your facility has received. 3. Enter the quantity of the affected product you wish to be replaced in the Quantity to be Replaced column. Enter a 0 if you do not require any replacements for this lot. 4. Dispose of any affected inventory per your facility s policies and procedures." "NOTE: If you are a distributor who has physically shipped this product to another location, such as a customer or end user, please provide this letter to the recipient of the product so that the requested actions above may be completed."
• Quantity in Commerce: 290 devices
• Distribution: NC, WV, CA, PA, AL, TX
• 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.

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