Class 2 Device Recall AVANOS MICKEY SF Gastrostomy Feeding Tube

• Date Initiated by Firm: July 29, 2020
• Create Date: September 17, 2020
• Recall Status: Terminated on January 31, 2023
• Recall Number: Z-2969-2020
• Recall Event ID: 86244
• 510(K)Number: K122653
• Product Classification: Tubes, gastrointestinal (and accessories) - Product Code KNT
• Product: AVANOS MIC-KEY SF Gastrostomy Feeding Tube
• Code Information: REF Product Code: 7120-12-1.0; Size 12Fr, 1.0 cm; Lot # 30041194 REF Product Code: 7120-12-1.7; Size: 12Fr, 1.7 cm; Lot # 30039482 REF Product Code: 7120-12-4.5; Size: 12Fr, 4.5cm; Lot # 30057268 REF Product Code: 7120-14-0.8; Size:14Fr, 0.8cm; Lot # 30020939 REF Product Code: 7120-14-1.0; Size: 14Fr, 1.0cm; Lot # 30012320, 30020940 REF Product Code: 7120-14-1.2; Size: 14Fr, 1.2cm; Lot # 30020941, 30046143 REF Product Code: 7120-14-1.5; Size: 14Fr, 1.5cm; Lot # 30012322, 30027259 REF Product Code: 7120-14-1.7; Size: 14Fr, 1.7cm; Lot # 30012323 REF Product Code: 7120-14-2.0; Size:14Fr, 2.0cm; Lot # 30012326, 30018098 REF Product Code: 7120-14-2.3; Size: 14Fr, 2.3cm; Lot # 30018099 REF Product Code: 7120-14-2.5; Size: 14Fr, 2.5cm; Lot # 30012328 REF Product Code: 7120-14-2.7; Size: 14Fr, 2.7cm; Lot # 30012324 REF Product Code: 7120-14-3.0; Size: 14Fr, 3.0cm; Lot # 30012327 REF Product Code: 7120-14-3.5; Size: 14Fr, 3.5cm; Lot # 30041187 REF Product Code: 7120-16-5.5; Size: 16Fr, 5.5cm; Lot # 30046156 REF Product Code: 7140-12-1.5; Size: 12Fr, 1.5cm; Lot # 30015733 REF Product Code: 7140-14-0.8; Size: 14Fr, 0.8cm; Lot # 30020938 REF Product Code: 7140-14-1.0; Size: 14Fr, 1.0cm; Lot # 30072145, 30020061 REF Product Code: 7140-14-1.2; Size: 14Fr, 1.2cm; Lot # 30020062 REF Product Code: 7140-14-1.5; Size: 14Fr, 1.5cm; Lot # 30020063 REF Product Code: 7140-14-1.7; Size: 14Fr, 1.7cm; Lot # 30020064, 30049920 REF Product Code: 7140-14-2.0; Size: 14Fr, 2.0cm; Lot # 30020065 REF Product Code: 7140-14-2.3; Size: 14Fr, 2.0cm; Lot # 30020066 REF Product Code: 7140-14-2.5; Size: 14Fr, 2.5cm; Lot # 30020067 REF Product Code: 7140-14-3.5; Size: 14Fr, 3.5cm; Lot # 30021846 REF Product Code: 7140-14-4.0; Size: 14Fr, 4.0cm; Lot # 30021847 REF Product Code: 7140-14-4.5; Size: 14Fr, 4.5cm; Lot # 30021848 REF Product Code: 7140-14-5.0; Size: 14Fr, 5.0cm; Lot # 30044458 REF Product Code: 7140-16-1.0; Size: 16Fr, 1.0cm; Lot # 30058995 REF Product Code: 7140-16-1.5; Size: 16Fr, 1.5cm; Lot # 30021429 REF Product Code: 7140-16-2.3; Size: 16Fr, 2.3cm; Lot # 30021432, 30057743 REF Product Code: 7140-16-2.5; Size: 16Fr, 2.5cm; Lot # 30052745 REF Product Code: 7140-18-2.3; Size: 18Fr, 2.3cm; Lot # 0002968773 REF Product Code: 7140-18-5.5; Size: 18Fr, 5.5cm; Lot # 30052898 REF Product Code: 7140-20-2.0; Size: 20Fr, 2.0cm; Lot # 30054211
• Recalling Firm/ Manufacturer: Avanos Medical, Inc.; 5405 Windward Pkwy; Alpharetta GA 30004-3894
• For Additional Information Contact: Monica King; 470-448-5591
• Manufacturer Reason for Recall: Devices had cracked or detached from the feeding tube body
• FDA Determined Cause: Under Investigation by firm
• Action: Avanos issued urgent product safety advisory notice on august 12, 2020. It states the following: 1. CHECK all storage and usage locations to determine if any impacted product remains 2. DISCONTINUE using the impacted product 3. If you have UNUSED INVENTORY: " SEGREGATE and QUARANTINE the devices according to your facilitys procedures " IMMEDIATELY COMPLETE and RETURN the Acknowledgement Form and return to Avanos. Please email form to avanos7528@stericycle.com or FAX to 877- 857-4143 . Please note that Avanos is contracting with Stericycle to help manage this Advisory Notice communication. Please contact Avanos directly at 678-488-8563 to obtain replacement feeding tube(s) or to be issued a credit. 4. If the INVENTORY ALREADY USED OR IN-USE " IMMEDIATELY COMPLETE the Acknowledgement Form. If no impacted devices remain in your facilitys inventory, please check the box indicating that you have no inventory remaining. " For your patients who have been provided impacted devices and are currently using a MIC-KEY SF Gastrostomy Feeding please contact each patient and advise them to follow one of the following scenarios 1. Patient is currently using an impacted device? a. Not all feeding port hubs will detach from the feeding tube, but it may happen at any time after placement (e.g., soon after placement of the feeding tube or months after use): b. If the patient has a mature stoma, please advise patient to replace the impacted MIC-KEY SF Gastrostomy Feeding Tube with a different model feeding tube having a comparable size. c. If the patient has an immature stoma, consider replacing the feeding tube now, or taping over the hub as described below. d. If you and your patient decide not to replace the device, please advise patient to check on the tube and feeding port hub frequently throughout the day for cracks or potential leaks or detachment (a leak around the feeding port hub could mean that detachment may occur). If leakage around the feedi
• Quantity in Commerce: 284 units
• Distribution: US states: OK IL WI PA TX IL PA NJ OK LA OUS: Belgium
• 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 = KNT and Original Applicant = KIMBERLY-CLARK CORPORATION