The Recall Desk
HighFDA (Devices)·Z-2761-2016·Announced 2016-09-14

Riverpoint Medical Recalls Nylon Surgical Sutures Due to Seal Integrity Issues

Riverpoint Medical is recalling sterile nylon surgical sutures because the seals may become open during distribution or packaging.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device where the loss of sterility (due to open seals) poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Riverpoint Medical, LLC is recalling sterile nylon surgical sutures sold under the brand names Riverlon, Securolon, and Weblon. The recall is being conducted because the product seals may become open during distribution or subsequent packaging. The affected products are used for general soft tissue approximation and ligation, including in cardiovascular, ophthalmic, and neurological surgery.

The recall includes part numbers 663BK, 663BL, 664BL, and 928BK. Specific lot numbers are identified for both human and veterinary use. A total of 2,110 boxes were distributed in the United States and 72 boxes were distributed outside the US. Distribution in the US was nationwide, specifically in the states of Idaho, Massachusetts, Oregon, and New York, as well as in Australia.

Consumers and healthcare providers should stop using the affected sutures and contact Riverpoint Medical for further instructions or a replacement.

The recalled product

Product
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, oph

Distribution

Distributed nationwide across the United States.

The notice also names 5 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Riverpoint Medical, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →