FDA Enforcement
Class II
Terminated
Medical Action INDUSTRIES INC. Port a Cath Kit REF 58647D, cardiac catheter introduction kit
Recall: Z-0751-2023
·
Reported December 28, 2022
Enforcement
- Recall Number
- Z-0751-2023
- Event ID
- 91180
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Medical Action Industries, Inc. 306
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- December 28, 2022
- Initiation Date
- November 4, 2022
- Classification Date
- December 21, 2022
- Termination Date
- March 18, 2026
- Address
- 25 Heywood Rd, Arden, NC, 28704-9302, United States
Description
Medical Action INDUSTRIES INC. Port a Cath Kit REF 58647D, cardiac catheter introduction kit
Reason
XXX
Code Info
UDI/DI 10809160156681, Lot Numbers: 297223, 297418
Distribution
US Nationwide distribution in the state of VA.
Quantity
198 cases