Recall archive / FDA device enforcement
AVNS ambIT System - PIB/PCA W 5in Cath, Product Code: 220507 — FDA record Z-1685-2023
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Apr 24, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- AVNS ambIT System - PIB/PCA W 5in Cath, Product Code: 220507
- Reason
- Some of the ambIT kits were potentially distributed without an air in-line filter.
- Classification
- Class II
- Recalling firm
- Avanos Medical, Inc.
- Quantity
- 57 cases (285 cassettes)
- Agency-reported status
- Terminated
- Source record identifier
- Z-1685-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot Number (Expiration Date): 30177647 (17 Dec 2023); 30174128 (14 Oct 2023) |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution - US Nationwide distribution in the states of Texas and Oregon. The country of Australia.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Jun 14, 2023
- Recall initiation date
- Apr 24, 2023
- Center classification date
- Jun 6, 2023
- Termination date
- Aug 2, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.