Polyglycolic-Lactic Acid Absorbable Surgical Suture Label reads in part "Coated VILET *** (Polyglacin 910) Suture UNDYED
FDA device recall Z-0347-2014 · posted 2013-11-18 · Terminated
Recall details
- Recalling firm
- Riverpoint Medical, LLC
- Reason for recall
- Riverpoint Medical is recalling PGLA Surgical Suture (Vilet) because the label indicates the suture is undyed and it is actually a violet colored suture.
- Action taken
- Riverpoint sent an Urgent Medical Device Recall letter in December 2012 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were requested to review their inventory and immediately quarantine the product in question, if found. In addition, if they have further distributed the recalled product, the consignees were advised to identify their customers and notify them of this product recall. All affected product is to be returned to Riverpoint Medical. Consignees were asked to call 503-517-8001 to return recalled product and request a credit or replacement. For questions regarding this recall call 503-517-8001.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- NEW
- Quantity affected
- 1932 pieces
- Distribution
- US Distribution in the states of: AZ, FL, and TX.
- Date initiated
- 2012-12-13
- Date posted
- 2013-11-18
- Date terminated
- 2013-11-21
- Location
- Portland, OR
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PDM, VILET, VILET QUICK, MONO Q, PLAIN GUT:# 6 CHROMIC GUT (K100461) | Riverpoint Medical | 2010-07-08 |