FDA Medical Device Recalls (openFDA)
Atrium Medical Corporation: Atrium 36Fr Right Angled Firm PVC Thoracic Catheter, (Pkg of 10) Part Number: 15236
- Recall number
- Z-2346-2015
- Recalling firm
- Atrium Medical Corporation
- Product
- Atrium 36Fr Right Angled Firm PVC Thoracic Catheter, (Pkg of 10) Part Number: 15236
- Status
- Terminated
- Initiated
- 2015-06-19
- Posted
- 2015-08-05
- Terminated
- 2016-03-21
- Reason
- Inner pouches incorrectly labeled as part 8136, 36Fr Right Angled Thermosensitive PVC catheter, but are part 15236-36Fr Right Angled Firm PVC Catheter
- Root cause
- Employee error
- Action
- Atrium Medical notified accounts by letter dated 6/18/15, explaining the mislabeled inner units. If any product is discovered with incorrect labeling, the product may be used or product may be returned for credit. contact your local Atrium/Maquet chest drainage representative or Atrium Customer Service at 1-800-528-7486 (603-880-1433), Monday through Friday between 8:00 am and 5:00 pm (EST).
- Quantity
- 62 cases (10/cs)=620 units
- Distribution
- AZ, CA, LA. IN, NC, TN, TX, VA
- Lot, serial or model codes
- Lot Number : ME215673 EXp: 2019/09
- 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