Terumo Cardiovascular Systems Corp: Medical Device Recall in 2022 - (Recall #: Z-0949-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.
Product Description:

Cardiovascular Procedure Kit catalog # 76645 & 73806

Product Classification:

Class II

Date Initiated: February 3, 2022
Date Posted: April 27, 2022
Recall Number: Z-0949-2022
Event ID: 89792
Reason for Recall:

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

Status: Terminated
Product Quantity: 64
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.

Voluntary or Mandated:

Voluntary: Firm initiated