FDA Medical Device Recalls (openFDA)
Boston Scientific Corp: Boston Scientific 10 Fr (3.3 mm) Flexima Regular APDL All Purpose Drainage catheter set; REF/catalog no. 27-135. Universal Product Number (UPN) M001271350.
- Recall number
- Z-0081-2007
- Recalling firm
- Boston Scientific Corp
- Product
- Boston Scientific 10 Fr (3.3 mm) Flexima Regular APDL All Purpose Drainage catheter set; REF/catalog no. 27-135. Universal Product Number (UPN) M001271350.
- Status
- Terminated
- Initiated
- 2006-09-21
- Posted
- 2006-10-28
- Terminated
- 2007-05-03
- Reason
- Sterility compromised/package integrity : the bottom of the Tyvek pouch may not have been sealed.
- Root cause
- Other
- Action
- Consignees were notified by letter dated 9/21/06 to discontinue use of recalled product, and to segregate the recalled product, and to follow instructions for responding to the firm and returning the product.
- Quantity
- 80
- Distribution
- Nationwide.
- Lot, serial or model codes
- Lot 8955327.
- 510(k) numbers
- ["K944290"]
- PMA numbers
- not on file
- Product code
- FFA
- 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