AVANOS MIC-KEY SF Gastrostomy Feeding Tube
Recall
- Recall Number
- Z-2969-2020
- Event Number
- 86244
- Firm
- Avanos Medical, Inc.
- FEI Number
- 3011270181
- Product Code
- KNT
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- July 29, 2020
- Terminated
- January 31, 2023
- Address
- 5405 Windward Pkwy, Alpharetta, GA, 30004-3894
Description
AVANOS MIC-KEY SF Gastrostomy Feeding Tube
Devices had cracked or detached from the feeding tube body
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 [email protected] 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
US states: OK IL WI PA TX IL PA NJ OK LA OUS: Belgium
284 units