FDA Medical Device Recalls (openFDA)
MEDLINE INDUSTRIES, LP - Northfield: Premier Rotaclone, Rx only
- Recall number
- Z-0552-2022
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- Premier Rotaclone, Rx only
- 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 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. An amended customer letter was sent on 12/17/2021. The explanation of the issue was updated. Instructions remained the same.
- Quantity
- 34 units
- Distribution
- US Nationwide distribution in the states of California and Massachusetts.
- Lot, serial or model codes
- Model Number: RID696004, Lot Number 696004N116, Expiration Date 01/12/2023
- 510(k) numbers
- ["K852969"]
- PMA numbers
- not on file
- Product code
- LIQ
- 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