Medical Device

Percutaneous Insertion Kit (PIK), Guidewire 100 cm, Model Numbers: 701053068 (USA), 701047384 (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

68371 units (1765 US, 66606 OUS)

Description

Percutaneous Insertion Kit (PIK), Guidewire 100 cm, Model Numbers: 701053068 (USA), 701047384 (OUS);