Recall record at a glance
| Official record | Z-1011-2019 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | US Endoscopy Group Inc. |
| Report date | Mar 20, 2019 |
| Recall initiation date | Feb 4, 2019 |
| Quantity | 483 units ( 325 units US and 158 OUS) |
| Location | Mentor, OH, United States |
Official product description
US Endoscopy Padlock Clip defect closure system Ref: C910001 The Padlock Clip is indicated for use in flexible endoscopy and for the compression of tissue in the gastrointestinal tract, for hemostasis or for treating lesions of the wall of the gastrointestinal organs.
Why the product was recalled
Potential esophageal laceration during a patient procedure
Distribution information
Worldwide Distribution: US (Nationwide) and countries of: Australia, Belgium, Czech Republic, Germany, Great Britain, India, Italy, Lebanon, Mexico, Netherlands, Norway, Philippines, S. Korea, Spain, Sweden and United Arab Emirates.
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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