Z-0081-2007

Boston Scientific 10 Fr (3.3 mm) Flexima Regular APDL All Purpose Drainage catheter set; REF/catalog no...

Name: Z-0081-2007 Boston Scientific 10 Fr (3.3 mm) Flexima Regular APDL All Purpose Drainage catheter set; REF/catalog no...
Creator: Boston Scientific Corp
Published: 2006-09-21
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2006-09-21 / Terminated / root cause: packaging

FDA source

Boston Scientific Corp began a recall of 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 on 2006-09-21. The reason FDA records is "Sterility compromised/package integrity : the bottom of the Tyvek pouch may not have been sealed". 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-0081-2007
Status: Terminated
Initiated: 2006-09-21
Posted: 2006-10-28
Terminated: 2007-05-03
Recalling firm: Boston Scientific Corporation
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.
Product code: FFA Tube, Drainage, Suprapubic
Reason for recall: Sterility compromised/package integrity : the bottom of the Tyvek pouch may not have been sealed.
Root cause tag: packaging
FDA 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 in commerce: 80
Distribution: Nationwide.
Product codes and lots: Lot 8955327.

Product code FFA

K944290Class IICatheters, Biliary Catheters, UrologicalBoston Scientific Corp / cleared 1994-12-08

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)