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.
What this means for you
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
- Hazard
- sterilization-failure
- inaccurate-expiration
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
Distributed in 14 states:
- AL
- AZ
- CA
- FL
- IA
- IL
- IN
- MD
- MI
- MN
- NJ
- PA
- TN
- TX
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