Device recall

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

FDA recall source

Recall number: Z-3146-2026
Event id: 99668
Status: Ongoing
FDA classification: Class II
Recalling firm: Maquet Cardiopulmonary Gmbh
Report date: Sep 23, 2026
Posted: Sep 11, 2026
Initiated: Jul 31, 2026
Center classification date: Sep 11, 2026
Product code: DWF
Device type: Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Reason: The packaging may not consistently maintain sterile barrier integrity.
Root cause: Packaging
Quantity: 16697 units (492 USA, 16205 OUS)
Code info: Model Number (USA): 701054427; UDI-DI: 4037691746517; Lot Numbers: 3000324476, 3000326923, 3000331200, 3000333822, 3000353373, 3000359477, 3000364060, 3000373784, 3000379853, 3000393466, 3000403658, 3000413596, 3000434593, 3000444270, 3000449725, 3000453328, 3000478750, 3000524542; Model Number (OUS): 701054427; UDI-DI: 4037691746517; Lot Numbers: 3000324476, 3000326923, 3000331200, 3000333821, 3000333822, 3000341452, 3000349478, 3000353373, 3000356330, 3000359477, 3000364060, 3000370472, 3000373784, 3000379853, 3000387894, 3000389007, 3000393466, 3000395576, 3000403658, 3000411197, 3000413596, 3000418475, 3000434593, 3000438011, 3000441822, 3000444270, 3000449725, 3000453328, 3000461221, 3000466027, 3000468435, 3000471532, 3000478750, 3000485149, 3000489899, 3000501535, 3000508513, 3000518008, 3000524542, 3000525465, 3000526923, 3000534009, 3000539532, 3000541224;
Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belarus, Belgium, Brazil, Canada, China, Colombia, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Italy, Japan, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom;
Voluntary or mandated: Voluntary: Firm initiated
Related 510(k)s: K131666
Location: Rastatt, N/A, Germany