FDA Medical Device Recalls (openFDA)
Atrium Medical Corporation: Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036.
- Recall number
- Z-0484-2024
- Recalling firm
- Atrium Medical Corporation
- Product
- Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036.
- Status
- Open, Classified
- Initiated
- 2023-09-29
- Posted
- 2023-12-02
- Terminated
- not on file
- Reason
- A sterilization nonconformance prematurely aged the product, resulting in an inaccurate labeled expiration date.
- Root cause
- Nonconforming Material/Component
- Action
- An Urgent Medical Device - Removal notice was sent via Fed-Ex on October 25, 2023. The letter advises customers to check for and remove from inventory Atrium Firm PVC Catheter 36 FR Straight, part number 15036, lot ME234686. Forward this information to all current and potential Atrium Firm PVC Thoracic Catheter 36FR Straight users within your hospital / facility, or to any customer product was further distributed to. Contact your local Atrium/Getinge Customer Service department at (603) 880-1433 (press option 1), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone)to request a return authorization (RMA) and shipping instructions to return any affected product.
- Quantity
- 2460 units (246 cases, 10 units/case)
- Distribution
- US: AL, AZ, CA, FL, IA, IL, IN, MD, MI, MN, NJ, PA, TN & TX
- Lot, serial or model codes
- UDI-DI: 00650862150360, lot ME234686, expiration date 2023-02-24.
- 510(k) numbers
- K831931
- PMA numbers
- not on file
- Product code
- GBZ
- Firm FEI
- 3011175548
- Firm city
- Merrimack
- Firm state
- NH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28