Z-3150-2024Class II

vanSonnenberg Sump Locking Pigtail Regular Kit Sump Catheter System Kit, Material Number REF M001273090; for...

Name: Z-3150-2024 vanSonnenberg Sump Locking Pigtail Regular Kit Sump Catheter System Kit, Material Number REF M001273090; for...
Creator: Boston Scientific Corporation
Published: 2024-07-18
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2024-07-18 / Open, Classified / root cause: packaging

FDA source

Boston Scientific Corporation began a recall of vanSonnenberg Sump Locking Pigtail Regular Kit Sump Catheter System Kit, Material Number REF M001273090; for use as a percutaneously placed drain for... on 2024-07-18. FDA classified it as Class II and gives the reason as "There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-3150-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-07-18
Posted: 2024-09-13
Recalling firm: Boston Scientific Corporation
Product: vanSonnenberg Sump Locking Pigtail Regular Kit Sump Catheter System Kit, Material Number REF M001273090; for use as a percutaneously placed drain for intra-abdominal fluid collections.
Product code: FFA Tube, Drainage, Suprapubic
Reason for recall: There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Boston Scientific issued am Urgent Medical Device Removal notice to it consignees on 07/18/2024 via overnight mail. The notice explained the issue, potential hazard, and requested the return of the devices. Consignees were directed to post the notice in a visible location near the affected products to ensure visibility and to share the notice with all those to whom the device was transferred. Distributors were direct to notify their customers.
Quantity in commerce: 4 units
Distribution: US, Colombia, Philippines, Russia
Product codes and lots: GTIN/UDI 0871472913774, Lot # 33512377, exp. 02/26/2027

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3150-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3147-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-25	2024-09-13
Z-3148-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-25	2024-09-13
Z-3149-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-25	2024-09-13
Z-3150-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-25	2024-09-13
Z-3151-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-25	2024-09-13

Product code FFA

K211934Class IIAPDL Drainage Catheter System, Flexima APDL Drainage Catheter System, Flexima APDL Drainage Catheter System Kit with Dissolving Tip, Flexima APDL Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System, Flexima APD Drainage Catheter System Kit, Flexima APD Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System Kit with Dissolving Tip, Flexima Quickstick Drainage Catheter System, vanSonnenberg Drainage Cateter System, vanSonnenbergBoston Scientific Corporation / cleared 2022-11-10

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)