Medical Device Recall: Percutaneous Insertion Kit (PIK), dilator set L, Model Numbers: 701054427 (USA), 701054427 (OUS);
Maquet Cardiopulmonary Gmbh · July 31, 2026
Reason for Recall
The packaging may not consistently maintain sterile barrier integrity.
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;
States Affected
NATIONWIDE
Quantity Affected
16697 units (492 USA, 16205 OUS)
Source: FDA (openFDA Device Enforcement)
Recall number: Z-3146-2026
Status: ongoing
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