Getinge PVC Thoracic Catheter, Soft PVC Right Angle, 10 per Case; Size(Model Number): 1. 24FR(8124), 2. 28FR(8128), 3. 32FR(8132), 4. 36FR(8136);
FDA Recall Z-3112-2026 · Posted 2026-09-04
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Recalling FirmAtrium Medical Corporation
Recall StatusOpen, Classified
Product CodeGBZ
Date Initiated2026-08-07
Product Quantity2533
Reason for Recall
An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.
Firm Action
On August 7, 2026 URGENT MEDICAL DEVICE - RECALL letters were sent to customers.
Customer Actions:
1. Please examine your inventory immediately to determine if you have any of the Atrium PVC Thoracic Catheters with the specific lot numbers.
2. Should you have any affected product, please remove from area(s) of use and quarantine.
3. 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.
4. Please contact 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 request a return authorization (RMA) and shipping instructions to return any affected product.
5. Whether or not you have affected product(s) within expiration listed in this notice, please complete and sign the attached MEDICAL DEVICE- REMOVAL RESPONSE FORM to acknowledge that you have received this notification. Return the completed form to Getinge by e-mailing a copy to [email protected].
Root Cause
Nonconforming Material/Component
Distribution Pattern
US Nationwide distribution.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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