Z-0949-2022 Class II Terminated
FDA device recall Z-0949-2022 was initiated by Terumo Cardiovascular Systems Corp on February 3, 2022 and is designated Class II. Reason for recall: Potential for Cardiovascular Procedure Kit packaging damage that occurred during shipping. The recall status is terminated (terminated February 20, 2024). Affected quantity: 64.
Recall Details
- Product Type
- Devices
- Report Date
- April 27, 2022
- Initiation Date
- February 3, 2022
- Termination Date
- February 20, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 64
Product Description
Cardiovascular Procedure Kit catalog # 76645 & 73806
Reason for Recall
Potential for Cardiovascular Procedure Kit packaging damage that occurred during shipping.
Distribution Pattern
US Nationwide distribution in the states of CA and IN.
Code Information
[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]