Cook Incorporated: Device Recall

Recall Details

Recall Number

Z-1786-2025

Classification

Class II

Product Type

Device

Recalling Firm

Cook Incorporated

Status

Ongoing

Date Initiated

04/17/2025

Location

Bloomington, IN, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

99 units

Reason for Recall

Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.

Product Description

Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF RCFW-10.0-0-38-30-RB, Order Number (GPN) REF G08686,

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Belgium, Germany, Spain, France, Ireland, Italy Netherlands, Switzerland, South Africa, Slovenia.

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 →