Atrium Medical Corporation recalls Getinge PVC Thoracic Catheter
Reason for recall
An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Getinge PVC Thoracic Catheter, Firm PVC Straight, 10 per Case; Size(Model Number): 1. 28FR(15028), 2. 36FR(15036);
Lot / code information
- Model
- (Size): 15028(28FR)
- UDI
- 00650862150285
- Lot #
- ME244891; 3
- Model
- (Size): 15036(36FR)
- UDI
- 00650862150360
- Lot #
- ME244850
What the firm is doing
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 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.
DistributionShow detailsHide
US Nationwide distribution.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-3113-2026
- FDA device classification · GBZOfficial FDA classification for this device type
- CFR regulation · 21 CFR 878.4200The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Atrium Medical CorporationSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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