Non-sterile procedural trays labeled as CRANI, 2 per case
FDA device recall Z-1029-2023 · posted 2023-01-27 · Open, Classified
Recall details
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- OJH
- Quantity affected
- 12 cases (24 units)
- Distribution
- US Nationwide distribution in the states of AR, MD, WA, WI.
- Date initiated
- 2022-11-17
- Date posted
- 2023-01-27
- Location
- Northfield, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.