FDA Medical Device Recalls (openFDA)
MEDLINE INDUSTRIES, LP - Northfield: HARDY DIAGNOSTICS CatScreen, 25dsk/vial
- Recall number
- Z-0554-2022
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- HARDY DIAGNOSTICS CatScreen, 25dsk/vial
- Status
- Terminated
- Initiated
- 2021-12-01
- Posted
- not on file
- Terminated
- 2023-01-09
- Reason
- Product stored incorrectly in temperature controlled setting instead of refrigeration.
- Root cause
- Process control
- Action
- Medline notified consignees on 12/01/2021, via first class mail letter titled URGENT RECALL NOTIFICATION. Customers were instructed to immediately check stock for affected product, quarantine any affected product on hand, complete and return the response form indicating product destroyed, and notify customers if the product was further distributed.
- Quantity
- 100 units (4 packs, 25 per pack)
- Distribution
- US Nationwide distribution in the state of California.
- Lot, serial or model codes
- Model Number HADZ110, all lots
- 510(k) numbers
- ["K960996"]
- PMA numbers
- not on file
- Product code
- JTO
- Firm FEI
- 1417592
- Firm city
- Northfield
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28