FDA Enforcement
Class I
Ongoing
Dover" IRRIGATION 1200 CC TRAY, 60 CC PISTON SYRINGE, STERILE SALINE, TIP PROTECTOR, ALCOHOL, LIDDED
Recall: Z-1049-2024
·
Reported February 28, 2024
Enforcement
- Recall Number
- Z-1049-2024
- Event ID
- 93551
- Classification
- Class I
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Cardinal Health 200, LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 28, 2024
- Initiation Date
- December 4, 2023
- Classification Date
- February 16, 2024
- Address
- 3651 Birchwood Dr, N/A, Waukegan, IL, 60085-8337, United States
Description
Dover" IRRIGATION 1200 CC TRAY, 60 CC PISTON SYRINGE, STERILE SALINE, TIP PROTECTOR, ALCOHOL, LIDDED
Reason
Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
Code Info
66820, Lot Numbers: 2217401764, 2305706564, 2200426764, 2201121964, 2212328164, 2213015364, 2213709164, 2215108864, 2232203764, 2312920864, 2313507064
Distribution
US and EMEA, Japan, Latin America
Quantity
63360 units