Recall Z-1684-2023 ยท FRN Pump, Infusion
Avanos Medical, Inc.
AVNS ambIT System - PIB/PCA W 2.5in Cath, Product Code: 220509
| Date | Jun 6, 2023 (initiated Apr 24, 2023) |
| Status | Terminated |
| Reason | Some of the ambIT kits were potentially distributed without an air in-line filter. |
| Root cause | Under Investigation by firm |
| Action | Avanos Medical notified customers on 04/24/2023 via email. Customers were instructed to evaluate their inventory of products to determine if any of the impacted product codes were present in their facility. The letter provided information identifying the affected product. It was indicated to segregate and contact Avanos to coordinate return/destruction of impacted product. Additionally, customers were instructed to complete and return the Acknowledgement Form. |
| Quantity | 33 cases (165 cassettes) |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of Texas and Oregon. The country of Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162165 | ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent Pump Summit Medical Products, Inc., Aug 29, 2017 |