Recall Z-3070-2024— 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: KIT PEDI CRANI LAMI, Pack Number DYNJ907372A. 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
KIT PEDI CRANI LAMI, Pack Number DYNJ907372A
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.