FDA Medical Device Recalls (openFDA)
Angiotech (Manan Medical Products, Inc.): J Type Bone Marrow Needle 13ga x 6cm - Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.
- Recall number
- Z-0816-2019
- Recalling firm
- Angiotech (Manan Medical Products, Inc.)
- Product
- J Type Bone Marrow Needle 13ga x 6cm - Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.
- Status
- Terminated
- Initiated
- 2018-12-18
- Posted
- not on file
- Terminated
- 2020-08-23
- Reason
- Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy Needle tray product line
- Root cause
- Equipment maintenance
- Action
- Argon Medical Devices notified customers on about 12/18/2018 via "Urgent - Field Safety Notice" letter. Instructions included complete and return the response form a quickly as possible, return all affected product to their Argon Wheeling facility, and to provide the recall notification to all who need to be aware within the organization as well as any organization where the affected product was distributed.
- Quantity
- 180 units
- Distribution
- Worldwide distribution - US Nationwide in the states of New Jersey, and countries of Mexico and South Korea.
- Lot, serial or model codes
- Model Number IMKBMN-13R-6, Lot Number LFD9
- 510(k) numbers
- ["K890925"]
- PMA numbers
- not on file
- Product code
- DWO
- Firm FEI
- 1417485
- Firm city
- Wheeling
- Firm state
- IL
- 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