Recall record at a glance
| Official record | Z-0568-2021 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Galt Medical Corporation |
| Report date | Dec 23, 2020 |
| Recall initiation date | Nov 16, 2020 |
| Quantity | 9,920 catheters (updated on 03/17/2021) |
| Location | Garland, TX, United States |
Official product description
Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-002-06 Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-006-16
Why the product was recalled
Due to a manufacturing issue, the catheter tip geometry is incorrect (thicker wall) resulting in a more obtuse tip angle.
Distribution information
U.S.: FL, GA, MA, NC, NJ, OH, PA, Puerto Rico and UT. O.U.S: Canada, Netherlands, Turkey, United Kingdom, and UAE
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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