Recall Z-2969-2020 ยท KNT Tubes, Gastrointestinal (And Accessories)
Avanos Medical, Inc.
AVANOS MIC-KEY SF Gastrostomy Feeding Tube
| Date | Jul 29, 2020 |
| Status | Terminated |
| Reason | Devices had cracked or detached from the feeding tube body |
| Root 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. |
| Quantity | 284 units |
| Distribution | US states: OK IL WI PA TX IL PA NJ OK LA OUS: Belgium |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122653 | MIC-KEY SF LOW PROFILE GASTROSTOMY TUBE AND ACCESSORIES Kimberly-Clark Corporation, Jun 26, 2013 |