Recall record at a glance
| Official record | Z-2761-2016 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Riverpoint Medical, LLC |
| Report date | Sep 14, 2016 |
| Recall initiation date | Aug 5, 2016 |
| Quantity | 2110 boxes distributed in the US and 72 boxes distributed outside US |
| Location | Portland, OR, United States |
Official product description
Nylon Surgical Suture for human use and vet use, sold under brand name Riverlon, Securolon, Weblon. Product is sterile. Part numbers: 663BK 663BL 664BL 928BK Product Usage: For use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurological surgery.
Why the product was recalled
Nylon Surgical Sutures are recalled because the seals may become open during distribution or subsequent packaging.
Distribution information
US Nationwide distribution in the states of ID, MA, OR, NY and in the country of Australia.
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: E-Mail.
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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