FDA Medical Device Recalls (openFDA)
Boston Scientific Corp: Boston Scientific vanSonnenberg Sump with ''J'' Tip, 30 cm, 14Fr (4.7 mm), for percutaneous abscess and fluid drainage, single use only, sterile; UPN M001202010, REF/Catalog No. 20-201.
- Recall number
- Z-1499-06
- Recalling firm
- Boston Scientific Corp
- Product
- Boston Scientific vanSonnenberg Sump with ''J'' Tip, 30 cm, 14Fr (4.7 mm), for percutaneous abscess and fluid drainage, single use only, sterile; UPN M001202010, REF/Catalog No. 20-201.
- Status
- Terminated
- Initiated
- 2006-08-10
- Posted
- 2006-09-13
- Terminated
- 2007-02-07
- Reason
- Lack of assurance of sterility, as the sterile barrier is weak and may be damaged on one edge.
- Root cause
- Other
- Action
- Consignee was notified via letter 8/10/06 to discontinue use of the product and to return it to the firm.
- Quantity
- 4 units
- Distribution
- Texas.
- Lot, serial or model codes
- Lot 8606405; exp. March 31, 2009.
- 510(k) numbers
- ["K811378"]
- PMA numbers
- not on file
- Product code
- GBW
- Firm FEI
- 1828132
- Firm city
- Spencer
- Firm state
- IN
- 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