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
E-Mail
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