FDA Enforcement
Class II
Terminated
Cardiovascular Procedure Kit catalog # 76645 & 73806
Recall: Z-0949-2022
·
Reported April 27, 2022
Enforcement
- Recall Number
- Z-0949-2022
- Event ID
- 89792
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Terumo Cardiovascular Systems Corp
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 27, 2022
- Initiation Date
- February 3, 2022
- Classification Date
- April 18, 2022
- Termination Date
- February 20, 2024
- Address
- 28 Howe St, Ashland, MA, 01721-1305, United States
Description
Cardiovascular Procedure Kit catalog # 76645 & 73806
Reason
Potential for Cardiovascular Procedure Kit packaging damage that occurred during shipping.
Code Info
[Lot #Z15957677, case label GTIN: (01)00699753507685, product identifier: (17)230228(10)Z15957677] and [Lot #Z16958398, case label GTIN: (01)00699753477728, product identifier: (17)230228(10)Z16958398]
Distribution
US Nationwide distribution in the states of CA and IN.
Quantity
64