FDA Medical Device Recalls (openFDA)
Medline Industries Inc: Control, Calibrator Verified, Triage BNP, Model ALR88755
- Recall number
- Z-3054-2020
- Recalling firm
- Medline Industries Inc
- Product
- Control, Calibrator Verified, Triage BNP, Model ALR88755
- Status
- Terminated
- Initiated
- 2020-07-28
- Posted
- not on file
- Terminated
- 2023-02-13
- Reason
- Product was shipped with refrigeration (ice) instead of frozen (dry ice).
- Root cause
- Process control
- Action
- Medline Industries sent formal letters with response forms to affected consignees via 1st class mail on August 3, 2020. Customers were asked to initiate sub-recalls where appropriate. Consignees were provided with a destruction form to return via fax or email. Each destruction form received with be recorded and Medline Industries, Inc. will send subsequent letters to consignees that have not provided a response to the recall notification in the allotted time. Consignees are asked to confirm the destruction of any affected product on hand.
- Quantity
- 118 units
- Distribution
- Distribution in US - AR, AZ, CO, FL, MD, MS, MI, NC, NM, NY, OK, PA, RI, TX
- Lot, serial or model codes
- Lot Number and/or Serial Number: 30718, 407522, 420694, 422646, 430000, 422647N, 422648N, 428255N,428256N, 441421N, 441422N, 441423N
- 510(k) numbers
- ["K072892"]
- PMA numbers
- not on file
- Product code
- JJY
- 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