Recall Z-3071-2024— MEDLINE INDUSTRIES, LP - Northfield
Class II · Ongoing
Class II FDA medical device recall by MEDLINE INDUSTRIES, LP - Northfield, initiated 2024-06-18. FDA's recall record names no specific 510(k) clearance for this event. Product: ANESTHESIA TURNOVER KIT, Pack Number DYNJAA0377. Reason: A non-sterile Mastisol component, which was not labeled as being sterile or non-sterile, was placed in the non-sterile portion of certain sterile convenience kits and distributed. In the event that the user assumes sterility during its use, there is an increased risk of patient infection..
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-06-18
- Firm location
- Northfield, IL, United States
Product description
ANESTHESIA TURNOVER KIT, Pack Number DYNJAA0377
Reason for recall
A non-sterile Mastisol component, which was not labeled as being sterile or non-sterile, was placed in the non-sterile portion of certain sterile convenience kits and distributed. In the event that the user assumes sterility during its use, there is an increased risk of patient infection.
Data sourced from openFDA. This site is unofficial and independent of the FDA.