Recall record at a glance
| Official record | Z-0890-2017 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Medtronic |
| Report date | Dec 28, 2016 |
| Recall initiation date | Oct 4, 2016 |
| Quantity | 230 systems |
| Location | North Haven, CT, United States |
Official product description
Best Practices kits containing certain production lots of Clearify Visualization System Item Code: 21-345 Intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope as well as clean the scope lens
Why the product was recalled
Product sterility is compromised due to breach of the sterile barrier
Distribution information
Worldwide Distribution - US (Nationwide) Foreign: Austria Belgium Bulgaria Brazil Chile Cyprus Denmark Egypt Finland France France Germany Greece Hungary Iran Ireland Israel Italy Japan Kenya Kuwait Latvia Luxembourg Mexico Namibia Netherlands Nigeria Norway Poland Portugal Romania Saudi Arabia Serbia Slovakia South Africa Spain Sweden Switzerland Turkey United Arab Emirates United Kingdom
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.
FDA source limitation: openFDA enforcement reports are a reference dataset, not a live public-alert or recall-lifecycle service. FDA notes that enforcement-report status may not be updated after classification. Confirm current actions with the FDA, recalling firm or appropriate healthcare professional when relevant.