FDA Enforcement
Class II
Ongoing
Medline convenience kits containing semi-rigid suction liners labeled as follows: KIT NEURO SHUNT ST LOUIS CHILD, Pack Number DYNJ907829B
Recall: Z-3117-2024
·
Reported September 18, 2024
Enforcement
- Recall Number
- Z-3117-2024
- Event ID
- 95128
- 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
- June 27, 2024
- Classification Date
- September 11, 2024
- Address
- 3 Lakes Dr, Northfield, IL, 60093-2753, United States
Description
Medline convenience kits containing semi-rigid suction liners labeled as follows: KIT NEURO SHUNT ST LOUIS CHILD, Pack Number DYNJ907829B
Reason
Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the potential loss of suction or low suction during intermittent suction use.
Code Info
DYNJ907829B: UDI/DI case 40195327077991, UDI/DI each 10195327077990, Lot Numbers: 23LMA774, 23LME672, 24AMA991, 24CMB554, 24CMB648
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Panama.
Quantity
134 units