Medical Device

Percutaneous Insertion Kit (PIK), dilator set L, Model Numbers: 701054427 (USA), 701054427 (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

16697 units (492 USA, 16205 OUS)

Description

Percutaneous Insertion Kit (PIK), dilator set L, Model Numbers: 701054427 (USA), 701054427 (OUS);