Recall record at a glance
| Official record | Z-2249-2018 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Vascular Solutions, Inc. |
| Report date | Jun 27, 2018 |
| Recall initiation date | May 4, 2018 |
| Quantity | 276 units |
| Location | Maple Grove, MN, United States |
Official product description
Drainer(R) Centesis Catheters: (a) REF 8810, 5F x 9cm (b) REF 8811, 6F x 9cm (c) REF 8812, 5F x 15cm Product The Drainer centesis catheter is intended for use in percutaneous fluid aspirations and small volume drainage procedures.
Why the product was recalled
The supplier of Drainer(R) centesis catheters notified Vascular Solutions, Inc. that there is a potential for certain production lots to contain unsafe levels of bacterial endotoxins.
Distribution information
US Nationwide Distribution
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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