Class 2 Device Recall EASYGRIP FLO41US

• Date Initiated by Firm: June 15, 2021
• Create Date: July 26, 2021
• Recall Status: Terminated on January 12, 2024
• Recall Number: Z-2051-2021
• Recall Event ID: 88074
• 510(K)Number: K193137
• Product Classification: Laparoscope, general & plastic surgery - Product Code GCJ
• Product: EASYGRIP FLO-41 US. For delivering hemostatic agents to bleeding sites through a trocar.
• Code Information: Product Code: ADS201897. Lot Numbers: 0000266641, 0000325839, 0000362640, 0000380266.
• Recalling Firm/ Manufacturer: Baxter Healthcare Corporation; 1 Baxter Pkwy; Deerfield IL 60015-4625
• For Additional Information Contact: Center for One Baxter; 847-948-4770
• Manufacturer Reason for Recall: There is a discrepancy in the expiry date encoded into the 2D barcode. The correct expiration date is the human-readable date
• FDA Determined Cause: Employee error
• Action: On June 15th 2021, the firm sent a letter to its customers with the following instructions: 1. Healthcare providers may continue to safely use the EASYGRIP FLO-41 delivery system while following the human readable expiry date printed on the primary and secondary package labeling, which are also listed in the table above. 2. If you received this communication directly from Baxter, complete the enclosed Baxter customer reply form and return it to Baxter by e-mailing it to fca@baxter.com, even if you do not have any inventory. Returning the customer reply form promptly will confirm your receipt of this notification and prevent you from receiving repeat notices. If you do not return the customer reply form, you will receive a phone call from OnProcess Technology on behalf of Baxter to confirm your receipt of this notification. 3. If you distribute this product to other facilities or departments within your institution, please forward a copy of this communication to them.
• Quantity in Commerce: 4,752 units
• Distribution: United States, Australia, Hong Kong, New Zealand, Belgium, Cyprus, Ireland, Italy, Netherlands, Norway, Portugal, Spain, Sweden, and United Kingdom.
• 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

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