Recall record at a glance
| Official record | Z-1384-2021 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Covidien, LP |
| Report date | Apr 21, 2021 |
| Recall initiation date | Mar 4, 2021 |
| Quantity | 11391 units WW: 5982 US 5409 OUS |
| Location | North Haven, CT, United States |
Official product description
Covidien Signia Grey Small Diameter Curved Tip Intelligent Reload 30 mm Vascular 8 mm - Short Item Code: SIGSDS30CTV
Why the product was recalled
Potential for the device safety interlock to fail. The safety interlock prevents an empty single-use reload from being erroneously fired a second time. If the safety interlock fails and the empty single-use reload is fired a second time, the stapler may cut tissue but no staples will deploy from the empty reload, potentially resulting in a failed anastomosis, bleeding, tissue trauma, and the potential need to convert to an open procedure.
Distribution information
Worldwide distribution - US Nationwide distribution and the countries of Austria, Belgium, Chile, China, Denmark, Finland, France, Germany, Hong Kong, Ireland, Italy, Netherlands, Norway, Poland, Portugal, Spain, Sweden, Switzerland, 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.
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