Class 2 Device Recall Remington MEDICAL

• Date Initiated by Firm: November 03, 2023
• Date Posted: December 05, 2023
• Recall Status: Open, Classified
• Recall Number: Z-0487-2024
• Recall Event ID: 93377
• 510(K)Number: K990428
• Product Classification: Bag, bile collecting - Product Code EXF
• Product: Remington MEDICAL Drainage Bag, REF 600-D
• Code Information: UDI/DI 20813079020008, Lot Number 2325111
• FEI Number: 1000132370
• Recalling Firm/ Manufacturer: Remington Medical, Inc.; 6830 Meadowridge Ct; Alpharetta GA 30005-2202
• For Additional Information Contact: 770-888-8520
• Manufacturer Reason for Recall: There is an error with the "Use by Date" and "Date of Manufacturer" on the box label.
• FDA Determined Cause: Labeling mix-ups
• Action: Remington Medical issued an URGENT: RECALL NOTIFICATION LETTER to its consignees on 11/03/2023 via email. The notice explained the issue, the potential risk, and requested the notice be communicated to all parties to whom it was distributed. If allowed by the consignee's internal procedures, remove the pouches from the box, as the pouch label correctly identifies the actual Date of Manufacture date and Use By date. The firm will replace the affected devices.
• Quantity in Commerce: 3080 devices
• Distribution: US: PA and FL
• 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 = EXF