Cook Incorporated: Medical Device Recall in 2024 - (Recall #: Z-1528-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Peel-Away Introducer - Intended for the percutaneous introduction of balloon, electrode and closed or non-tapered end catheters into central and peripheral vasculature, and for nonvascular use. REFERENCE PART NUMBER (RPN)/ ORDER NUMBER (GPN): 1)PLVW-7.0-35 G00925 2)PLVW-8.0-35 G01844 : DTVN-5.0-19-10.0- YUEH : G09490

Product Classification:

Class II

Date Initiated: March 1, 2024

Date Posted: April 24, 2024

Recall Number: Z-1528-2024

Event ID: 94196

Reason for Recall:

Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility

Status: Ongoing

Product Quantity: 55 units

Code Information:

UDI-DI/Lot Number: 1) (01)00827002009257(17) 15777767 2) (01)00827002018440(17) NS15787532

Distribution Pattern:

Worldwide distribution - US Nationwide and the countries of AT, AU, BR, CA, CH, DE, ES, GB, HK, IE, IL, IN, IT, NZ, SG.

Voluntary or Mandated:

Voluntary: Firm initiated