Device product

Cardiovascular Procedure Kit catalog # 76645 & 73806

Z-0949-2022

February 03, 2022

Class II

Product summary

Firm: Terumo Cardiovascular Systems Corp
Event: Event 89792
Status: Terminated
Classification: Class II
Quantity: 64
Official record key: device-enforcement:Z-0949-2022

Official wording

Reason: Potential for Cardiovascular Procedure Kit packaging damage that occurred during shipping.

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]

Distribution pattern: US Nationwide distribution in the states of CA and IN.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Potential for Cardiovascular Procedure Kit packaging damage that occurred during shipping.