Z-1499-06

Boston Scientific vanSonnenberg Sump with ''J'' Tip, 30 cm, 14Fr (4.7 mm), for percutaneous abscess and fluid...

Name: Z-1499-06 Boston Scientific vanSonnenberg Sump with ''J'' Tip, 30 cm, 14Fr (4.7 mm), for percutaneous abscess and fluid...
Creator: Boston Scientific Corp
Published: 2006-08-10
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2006-08-10 / Terminated / root cause: packaging

FDA source

Boston Scientific Corp began a recall of Boston Scientific vanSonnenberg Sump with ''J'' Tip, 30 cm, 14Fr (4.7 mm), for percutaneous abscess and fluid drainage, single use only, sterile; UPN... on 2006-08-10. The reason FDA records is "Lack of assurance of sterility, as the sterile barrier is weak and may be damaged on one edge". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1499-06
Status: Terminated
Initiated: 2006-08-10
Posted: 2006-09-13
Terminated: 2007-02-07
Recalling firm: Boston Scientific Corporation
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.
Product code: GBW Catheter, Peritoneal
Reason for recall: Lack of assurance of sterility, as the sterile barrier is weak and may be damaged on one edge.
Root cause tag: packaging
FDA 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 in commerce: 4 units
Distribution: Texas.
Product codes and lots: Lot 8606405; exp. March 31, 2009.

Product code GBW

K811378Class IPercutaneous Draining CatheterMedi-Tech, Inc. / cleared 1981-06-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)