FDA Enforcement
Class II
Ongoing
Medline Convenience kits labeled as: PUH ESOPHAGECTOMY CDS, Pack Number CDS984309I
Recall: Z-3008-2024
·
Reported September 18, 2024
Enforcement
- Recall Number
- Z-3008-2024
- Event ID
- 94583
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- MEDLINE INDUSTRIES, LP - Northfield
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- September 18, 2024
- Initiation Date
- April 8, 2024
- Classification Date
- September 6, 2024
- Address
- 3 Lakes Dr, Northfield, IL, 60093-2753, United States
Description
Medline Convenience kits labeled as: PUH ESOPHAGECTOMY CDS, Pack Number CDS984309I
Reason
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Code Info
CDS984309I, Lot Number 22DBK534
Distribution
Worldwide distribution.