Z-3146-2026 Class II Ongoing
FDA device recall Z-3146-2026 was initiated by Maquet Cardiopulmonary Gmbh on July 31, 2026 and is designated Class II. Reason for recall: The packaging may not consistently maintain sterile barrier integrity. The recall status is ongoing. Affected quantity: 16697 units (492 USA, 16205 OUS).
Recall Details
- Product Type
- Devices
- Report Date
- September 23, 2026
- Initiation Date
- July 31, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16697 units (492 USA, 16205 OUS)
Product Description
Percutaneous Insertion Kit (PIK), dilator set L, Model Numbers: 701054427 (USA), 701054427 (OUS);
Reason for Recall
The packaging may not consistently maintain sterile barrier integrity.
Distribution Pattern
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;
Code Information
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;