DeviceSignal · Recall classified
Atrium Medical Corporation
FDA classified a device recall on 2026-09-04 · Class II · Z-3113-2026
EventRecall classified
Effective2026-09-04
ClassificationClass II
On 2026-09-04 the FDA classified a device recall from Atrium Medical Corporation as Class II. Product: Getinge PVC Thoracic Catheter, Firm PVC Straight, 10 per Case; Size(Model Number): 1…. Recall Z-3113-2026. The firm initiated it on 2026-08-07. This reports the classification FDA published on that date.
Reported facts
- Recall number
- Z-3113-2026
- Classification
- Class II
- Classified on
- 2026-09-04
- Initiated on
- 2026-08-07
- Firm
- Atrium Medical Corporation
- Reason
- An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.
- Product
- Getinge PVC Thoracic Catheter, Firm PVC Straight, 10 per Case; Size(Model Number): 1. 28FR(15028), 2. 36FR(15036);
Every field above is as fda_device_enforcement published it. Nothing on this page is our interpretation.
Provenance
- Source
- fda_device_enforcement
- Source record
Z-3113-2026- Snapshot hash
e8e634c086f9f5f52e82a7eef6331d8800209bbb8cbb79bd654d29f1222caae4- Source URL
- https://download.open.fda.gov/device/enforcement/device-enforcement-0001-of-0001.json.zip
- Observed
- 2026-09-23T12:43:31.676Z
- Transform
fda_device_enforcement_to_recall v1- Event rule
fda_device_recall_classified v1- Event key
177011a1ba764656d2bf79ca06d07cebcbc41f08a0a654f9a6238f65cadcf3fd- Signal type
device_recall.classified
Source terms that apply
- This is not a public alerting service and must not be used to notify patients or the public
- We do not report whether a recall is still open; FDA does not maintain that after classification
- Nothing here is a medical or clinical decision aid
- Not affiliated with, endorsed by, or certified by the FDA
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov)