Cook Incorporated: Device Recall

Recall Details

Recall Number

Z-0045-2025

Classification

Class II

Product Type

Device

Recalling Firm

Cook Incorporated

Status

Ongoing

Date Initiated

09/16/2024

Location

Bloomington, IN, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

50 units

Reason for Recall

Cook Medical is conducting removal of a lot of Check-Flo Performer Introducer Set due to complaints that the white caps that connect the shaft to the hub of these products may disconnect.

Product Description

Check-Flo Performer Introducer Set, Reference Part Number RCF-5.0-35-45-J, Order Number G27242. Performer Introducers are designed to perform as a guiding sheath and/or introducer sheath and come with a Check Flo valve.

Distribution Pattern

International distribution to the country of Australia.

Other Recalls by Cook Incorporated

• Class II: Risk 11/26/2025
  Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not correctly trimmed, and not inspected properly.
• Class II: Risk 11/26/2025
  Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not correctly trimmed, and not inspected properly.
• Class II: Risk 11/26/2025
  Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not correctly trimmed, and not inspected properly.
• Class I: Dangerous 05/15/2025
  Cook Medical identified that catheters supplied in the affected device lots may experience tip separation.
• Class II: Risk 04/17/2025
  Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.

View all recalls by Cook Incorporated →