FDA Medical Device Recalls (openFDA)
MEDLINE INDUSTRIES, LP - Northfield: Michels Transport Medium, 20ML Prefilled Cont
- Recall number
- Z-0656-2022
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- Michels Transport Medium, 20ML Prefilled Cont
- Status
- Terminated
- Initiated
- 2021-12-01
- Posted
- not on file
- Terminated
- 2023-02-13
- Reason
- Product stored incorrectly in temperature controlled setting instead of refrigeration.
- Root cause
- Process control
- Action
- Medline notified customer through first class mail on about 12/01/2021, via letter titled URGENT RECALL NOTIFICATION. Customers were instructed to immediately check stock and quarantine affected devices, return the completed provided response form indicating affected product on hand and destroyed, and to notify customers if affected product was further distributed. An amended customer letter was sent on 12/17/2021. The explanation of the issue was updated. Instructions remained the same.
- Quantity
- 2,816 units (22 cases, 128 per case)
- Distribution
- US Nationwide distribution in the states of Colorado, Florida, New York, North Carolina, and Texas.
- Lot, serial or model codes
- Model Number: AZSES3270, all lots with expiration date range of 08/28/2021 through 09/03/2023
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NNI
- 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