AVNS ambIT System - PIB/PCA W 5in Cath, Product Code: 220507
FDA device recall Z-1685-2023 · posted 2023-06-06 · Terminated
Recall details
- Recalling firm
- Avanos Medical, Inc.
- Reason for recall
- Some of the ambIT kits were potentially distributed without an air in-line filter.
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 57 cases (285 cassettes)
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of Texas and Oregon. The country of Australia.
- Date initiated
- 2023-04-24
- Date posted
- 2023-06-06
- Date terminated
- 2024-08-02
- Location
- Alpharetta, GA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent Pump (K162165) | Summit Medical Products, Inc. | 2017-08-29 |