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.
Reported: September 25, 2024 Initiated: July 18, 2024 #Z-3150-2024
Product Description
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.
Reason for Recall
There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.
Details
- Recalling Firm
- Boston Scientific Corporation
- Units Affected
- 4 units
- Distribution
- US, Colombia, Philippines, Russia
- Location
- Maple Grove, MN
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Boston Scientific Corporation. Units affected: 4 units.
Why was this product recalled? ▼
There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 25, 2024. Severity: Moderate. Recall number: Z-3150-2024.
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