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U.S. Department of Health and Human Services

Class 2 Device Recall Getinge PVC Thoracic Catheter

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 Class 2 Device Recall Getinge PVC Thoracic Cathetersee related information
Date Initiated by FirmAugust 07, 2026
Date PostedSeptember 04, 2026
Recall Status1 Open3, Classified
Recall NumberZ-3112-2026
Recall Event ID 99680
Product Classification Catheter, cholangiography - Product Code GBZ
ProductGetinge 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);
Code Information 1. Model Number(Size): 8124(24FR); UDI-DI: 00650862132243; Lot Number: ME244852; 2. Model Number(Size): 8128(28FR); UDI-DI: 00650862132281; Lot Number: ME244854, ME244855; 3. Model Number(Size): 8132(32FR); UDI-DI: 00650862132328; Lot Numbers: ME244565, ME244858, ME244859; 4. Model Number(Size): 8136(36FR); UDI-DI: 00650862132366; Lot Number: ME244861;
FEI Number 3011175548
Recalling Firm/
Manufacturer		 Atrium Medical Corporation
40 Continental Blvd
Merrimack NH 03054-4332
For Additional Information ContactMegan Ties
603-880-1433
Manufacturer Reason
for Recall		An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionOn 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 customersupport.us@getinge.com 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 recallresponses.qrc@getinge.com.
Quantity in Commerce2533
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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