Recall record at a glance
| Official record | Z-1641-2015 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Ethicon Endo-Surgery Inc. |
| Report date | May 27, 2015 |
| Recall initiation date | Feb 26, 2015 |
| Quantity | 6,744 devices |
| Location | Blue Ash, OH, United States |
Official product description
ENDOPATH ECHELON" Vascular White Reload for Advanced Placement Tip, Product Usage: The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic and pediatric surgical procedures.
Why the product was recalled
During an internal inspection of the production process the firm discovered an issue which may cause the cartridge to deploy an incomplete staple line.
Distribution information
Worldwide Distribution - US Nationwide in the states of: AR, AZ, CA, CO, DE, FL, GA, IA, IL, KS, KY, LA, MA, ME, MI, MN, MO, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA & WI and the country of Hong Kong.
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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