Recall Z-1369-2025— MEDLINE INDUSTRIES, LP - Northfield
Class II · Ongoing
Class II FDA medical device recall by MEDLINE INDUSTRIES, LP - Northfield, initiated 2025-02-13. FDA's recall record names no specific 510(k) clearance for this event. Product: Proxima Drape labeled as UNIVERSAL DAVINCI ROBOTIC P. Sterile surgical drape.. Reason: Potential breach in pouch packaging which could lead to loss of sterility..
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-02-13
- Firm location
- Northfield, IL, United States
Product description
Proxima Drape labeled as UNIVERSAL DAVINCI ROBOTIC P. Sterile surgical drape.
Reason for recall
Potential breach in pouch packaging which could lead to loss of sterility.
Data sourced from openFDA. This site is unofficial and independent of the FDA.