FDA Medical Device Recalls (openFDA)
Atrium Medical Corporation: Atrium PVC 8 Fr Straight Thoracic Catheter Code Number: 8008
- Recall number
- Z-1221-2017
- Recalling firm
- Atrium Medical Corporation
- Product
- Atrium PVC 8 Fr Straight Thoracic Catheter Code Number: 8008
- Status
- Terminated
- Initiated
- 2017-01-20
- Posted
- not on file
- Terminated
- 2020-11-03
- Reason
- Labeling icon depicts a catheter having six (6) eyelets; however the correct number of eyelets on the 8 Fr and 10 Fr thoracic catheters is two (2)
- Root cause
- Labeling design
- Action
- Marquet/Atrium notified consignees by letter dated 01/20/17 informing of the Labeling Icon Clarification. The thoracic catheter labeling is being updated for future production. Users should be made aware of this Field Notification and may continue to use the affected thoracic catheter products with the current labeling. Questions, please contact your local Maquet/Atrium thoracic catheter representative or Maquet Customer Service at 1-800-528-7486 or 603-880-1433, Monday through Friday between 8:00 am and 5:00 pm (EST).
- Quantity
- 660 cases (10/case)
- Distribution
- Nationwide
- Lot, serial or model codes
- All Lot Numbers With Expiration Date Prior To December 2019
- 510(k) numbers
- ["K831931"]
- PMA numbers
- not on file
- Product code
- GBZ
- Firm FEI
- 3011175548
- Firm city
- Hudson
- 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