Atrium Firm PVC Thoracic Catheter Recalled for Sterilization Nonconformance
Atrium Medical Corporation is recalling 2,460 units of the Atrium Firm PVC Thoracic Catheter 36FR Straight due to sterilization nonconformance that caused premature product aging and inaccurate expiration dating. Facilities in 14 U.S. states are affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device with sterilization nonconformance affecting a sterile thoracic catheter intended for body insertion. No illnesses or injuries reported, but sterilization process failures on body-contact medical devices present a material risk of harm per the rubric.
Plain-English summary
Atrium Medical Corporation is recalling 2,460 units of the Atrium Firm PVC Thoracic Catheter 36FR Straight (part number 15036, lot ME234686) distributed across the United States. The recall affects healthcare facilities in 14 states: Alabama, Arizona, California, Florida, Iowa, Illinois, Indiana, Maryland, Michigan, Minnesota, New Jersey, Pennsylvania, Tennessee, and Texas.
The recall is due to a sterilization nonconformance that prematurely aged the product. As a result, the expiration dates on the product labels do not accurately reflect the product's actual service life. The affected units bear lot number ME234686, UDI-DI 00650862150360, and labeled expiration date February 24, 2023.
This is a Class II recall, and no illnesses or injuries have been reported. Healthcare facilities should review their stock and contact Atrium Medical Corporation with questions regarding the affected product.
The recalled product
- Product
- Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036.
- Manufacturer
- Atrium Medical Corporation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- UDI-DI: 00650862150360
- lot ME234686
- expiration date 2023-02-24.
Distribution
Related recalls
Same manufacturer · Atrium Medical Corporation
See all →- HighAtrium Medical Recalls Getinge PVC Thoracic Catheters Due to Endotoxin Testing
FDA (Devices) · 2026-09-16
- HighAtrium Medical Recalls Getinge PVC Thoracic Catheters Due to Endotoxin Testing
FDA (Devices) · 2026-09-16
- HighAtrium Medical Recalls Getinge PVC Thoracic Catheters Due to Endotoxin Testing
FDA (Devices) · 2026-09-16
- ModerateiCast Covered Stent Recalled for Unique Device Identifier Labeling Error
FDA (Devices) · 2024-10-16
- HighVascular graft component separation reported in Advanta VXT devices
FDA (Devices) · 2024-06-12
Same hazard · sterilization failure
See all →- SevereSteris VERIFY Biological Indicator Recall Due to Spore Population Concerns
FDA (Devices) · 2026-10-14
- HighSteris VERIFY Dual Species Biological Indicator Recall for Spore Population Issues
FDA (Devices) · 2026-10-14
- SevereSteris VERIFY Biological Steam Test Pack Recalled for Spore Population Defect
FDA (Devices) · 2026-10-14
- SevereSteris VERIFY Biological/Integrator Challenge Pack Recall for Spore Population Defect
FDA (Devices) · 2026-10-14
- SevereSteris Recalls VERIFY Biological Steam Test Packs Due to Spore Population Concerns
FDA (Devices) · 2026-10-14
Similar recalls
- HighAtrium Firm PVC Thoracic Catheter Recall Due to Expiration Date Mismatch
FDA (Devices) · 2022-07-06
- ModerateAtrium 36Fr Right Angled Firm PVC Thoracic Catheter Recall
FDA (Devices) · 2015-08-12
- HighAtrium Medical Recalls 28Fr Thoracic Catheters Due to Seal Defect
FDA (Devices) · 2018-12-12
- HighAtrium Medical Recalls Getinge PVC Thoracic Catheters Due to Endotoxin Testing
FDA (Devices) · 2026-09-16
- ModerateAtrium Medical Recalls 8 Fr Thoracic Catheters Due to Labeling Error
FDA (Devices) · 2017-02-22
- ModerateAtrium Thoracic Catheter Recall Due to Incorrect Labeling Icon
FDA (Devices) · 2017-02-22