Recall archive / FDA device enforcement
BALLARD* Seal Cassette Replacement MAP - BALLARD* Seal Cassette Replacement for Multi-Access Port (MAP) Catheter; Ste... — FDA record Z-0845-2022
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 Nov 22, 2021. 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
- BALLARD* Seal Cassette Replacement MAP - BALLARD* Seal Cassette Replacement for Multi-Access Port (MAP) Catheter; Sterile; Single Use
- Reason
- Product was distributed with incorrect expiration date.
- Classification
- Class II
- Recalling firm
- Avanos Medical, Inc.
- Quantity
- 20 devices (1 case)
- Agency-reported status
- Terminated
- Source record identifier
- Z-0845-2022
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 | Finished Product Code: 102008602; Alternate Code: 24013-5; Lot No.: 30143745. |
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 Oklahoma and Ohio; The countries of China, France, Germany, Great Britain, Greece, Italy, and Netherlands.
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
- Apr 6, 2022
- Recall initiation date
- Nov 22, 2021
- Center classification date
- Mar 31, 2022
- Termination date
- Jan 31, 2023
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.