Medical Device

Percutaneous Insertion Kit (PIK), Guidewire 150 cm, Model Numbers: 701053069 (USA), 701047385 (OUS);

Recall date: 2026-09-23 · Source: FDA_DEVICE

Brand / Firm

Product

Reason for recall

The packaging may not consistently maintain sterile barrier integrity.

Units affected

185617 units (5926 US, 179691 OUS)

Description

Percutaneous Insertion Kit (PIK), Guidewire 150 cm, Model Numbers: 701053069 (USA), 701047385 (OUS);