AVNS ambIT System - PIB/PCA W 5in Cath, Product Code: 220507 recallZ-1685-2023 · Avanos Medical, Inc. · initiated Apr 24, 2023
Class II Terminated All recalls posted in June 2023
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Avanos Medical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Some of the ambIT kits were potentially distributed without an air in-line filter.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-1685-2023
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Apr 24, 2023
- Posted by the FDA
- Jun 6, 2023
- Recalling firm
- Avanos Medical, Inc.
- Quantity
- 57 cases (285 cassettes)
- Product code
- FRN
- FDA submissions
- K162165
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of Texas and Oregon. The country of Australia.
Product description
AVNS ambIT System - PIB/PCA W 5in Cath, Product Code: 220507
Code information (models, lots, serial numbers)
Lot Number (Expiration Date): 30177647 (17 Dec 2023); 30174128 (14 Oct 2023)
Other devices under the same FDA submission
4 devices cleared under K162165 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- ambIT* PIB*IL Pump 220527Avanos Medical, Inc. · Pump, infusion15 reports
- ambIT* PIB-PCA v1.5 System w/Spike Filter Cass 220574Avanos Medical, Inc. · Pump, infusion4 reports
- ambIT* PIB-PCA Pump 220501Avanos Medical, Inc. · Pump, infusion1 report
- ambIT* PIB IL v 1.5 220571Avanos Medical, Inc. · Pump, infusion, pca1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 92279).
- Z-1684-2023 · TerminatedAVNS ambIT System - PIB/PCA W 2.5in Cath, Product Code: 220509
- Z-1686-2023 · TerminatedSMMT ambIT Kit Basic Filter Luer Cass, Product Code: 220537
- Z-1687-2023 · TerminatedSMMT ambIT Reusable Program - Luer Cass, Product Code: 220568
- Z-1688-2023 · TerminatedambIT Cassette Filter Male Luer, Product Code: 220266
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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