Recalls / —

—#192439

Product

Cardiovascular Procedure Kit catalog # 76645 & 73806

FDA product code

OEZ — Cardiovascular Procedure Kit

Device class

Class 2

Medical specialty

Cardiovascular

Affected lot / 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]

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

A customer notification letter was issued on 02/23/2022 by 2-day FedEx mailing advising customers to remove the affected product from use and return to Terumo CVS using the instructions provided.

Recalling firm

Firm

Terumo Cardiovascular Systems Corp

Address

28 Howe St, Ashland, Massachusetts 01721-1305

Distribution

Distribution pattern

US Nationwide distribution in the states of CA and IN.

Timeline

Recall initiated

2022-02-03

Terminated

2024-02-20

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #192439. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.