Recall record at a glance
| Official record | Z-0803-2017 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Oscor, Inc. |
| Report date | Dec 28, 2016 |
| Recall initiation date | Oct 5, 2016 |
| Quantity | 74 |
| Location | Palm Harbor, FL, United States |
Official product description
OSCOR ADELANTE BREEZEWAY 10F C55 S79CM D84CM Catalog # AB101076 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
Why the product was recalled
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Distribution information
Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico. Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM
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: E-Mail.
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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