Percutaneous Insertion Kit (PIK), dilator set L, Model Numbers: 701054427 (USA), 701054427 (OUS);
FDA Recall Z-3146-2026 · Posted 2026-09-11
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Recalling FirmMaquet Cardiopulmonary Gmbh
Recall StatusOpen, Classified
Product CodeDWF
Date Initiated2026-07-31
Product Quantity16697 units (492 USA, 16205 OUS)
Reason for Recall
The packaging may not consistently maintain sterile barrier integrity.
Firm Action
On July 31, 2026 URGENT MEDICAL DEVICE REMOVAL letters were sent to customers.
Customer Actions:
1. Ensure all affected, unused product in your inventory has been properly quarantined.
2. Please ensure this message is forwarded to any individuals that need notification within your organization or any organization where the affected devices have been transferred.
3. Contact Customer Service via email at [email protected] or 888-943-8872, option 2 / (888 9GETUSA), Monday through Friday, between the hours of 8:00 a.m. and 5:00 p.m. (Eastern Time Zone) to return your unused, unexpired, affected product. Credit will be issued for returned product.
4. Complete and return the enclosed response form to Getinge by e-mailing a copy to
[email protected].
Root Cause
Packaging
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;
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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