FDA Medical Device Recalls (openFDA)
MEDLINE INDUSTRIES, LP - Northfield: Non-sterile procedural trays labeled as LAPAROTOMY CDS, 2 per case
- Recall number
- Z-1031-2023
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- Non-sterile procedural trays labeled as LAPAROTOMY CDS, 2 per case
- Status
- Open, Classified
- Initiated
- 2022-11-17
- Posted
- 2023-01-27
- Terminated
- not on file
- Reason
- Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the outer foil layer causing a breach in the sterile packaging.
- Root cause
- Device Design
- Action
- Medline Industries, LP notified consignees via email and first-class mail on 11/21/2022. Consignees were instructed to over-label the sterile kits with a warning label indicating Warning To Avoid Injury, Please Handle Blades with Care . For the Non-Sterile kits, they are to over label the affected kits indicating to remove the blades and replace from a different sterile supply. No product is to be returned. Customers were also instructed to complete and return the response form.
- Quantity
- 57 cases (114 units)
- Distribution
- US Nationwide distribution in the states of AR, MD, WA, WI.
- Lot, serial or model codes
- Item Number: CDS980894A, UDI/GTIN Case: 40889942401292, UDI/GTIN Each: 10889942401291, Lot Numbers: 22HMD613, 22JMB665
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FDE
- 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