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Terminated

AVNS ambIT System - PIB/PCA W 5in Cath, Product Code: 220507

FDA Recall Z-1685-2023 · Posted 2023-06-06

Recalling FirmAvanos Medical, Inc.
Recall StatusTerminated
Product CodeFRN
Date Initiated2023-04-24
Date Terminated2024-08-02
Product Quantity57 cases (285 cassettes)

Reason for Recall

Some of the ambIT kits were potentially distributed without an air in-line filter.

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.

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide distribution - US Nationwide distribution in the states of Texas and Oregon. The country of Australia.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K162165ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent PumpSummit Medical Products, Inc. · 2017-08-29

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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