Recall record at a glance
| Official record | Z-1481-2015 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Catheter Research, Inc. |
| Report date | Apr 29, 2015 |
| Recall initiation date | Apr 7, 2015 |
| Quantity | 880 units |
| Location | Indianapolis, IN, United States |
Official product description
HSG Trays/HS 5F Catheter Combo; HSG Procedure Tray+ Shapeable 5F HSG catheter. For hysterosonography and hysterosalpingography, gynecological use.
Why the product was recalled
HSG Trays and Catheters were mislabeled. Trays with the flexible HS catheter were labeled as containing the shapeable, stiffer HS catheter, and vice versa.
Distribution information
Domestic: MN, CA, OH, IL, FL, MA, WI, VA Foreign: None DOD/VA: None
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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