Recall record at a glance
| Official record | Z-1886-2018 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Ethicon Endo-Surgery Inc. |
| Report date | May 23, 2018 |
| Recall initiation date | Mar 26, 2018 |
| Quantity | 14873 |
| Location | Blue Ash, OH, United States |
Official product description
5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 75mm shaft length, 2B5ST
Why the product was recalled
Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. In addition, insufficient lubrication could result in a remote chance of introducing a minute particle if repeated insertions of the obturator or laparoscopic device damage the seal.
Distribution information
Nationwide domestic distribution, including PR. International distribution to Saudi Arabia, United Arab Emirates, Belgium, Singapore, Taiwan, South Korea, Canada, Chile, Mexico, Japan, and Argentina.
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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