Riverpoint Medical Recalls Velosorb Fast Sutures Due to Tensile Strength Defect
Riverpoint Medical is recalling specific lots of Velosorb Fast sutures because a manufacturing error may cause inadequate tensile strength, potentially leading to suture break or wound dehiscence.
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 with a defect that poses a risk of harm (suture break/wound dehiscence), but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Riverpoint Medical, LLC is recalling 3,060 units of Covidien CV-9590 Velosorb Fast Braided Fast absorbable Suture 14 Metric 36" 90 cm, GS-24 Taper 1/2 40 mm, undyed. The affected product is identified by Lot # 19062715X and UDI 10884521151307.
The recall was initiated due to a manufacturing error that may result in the sutures exhibiting inadequate tensile strength. This defect could potentially lead to intra-operative and post-operative complications, including suture break or wound dehiscence.
The affected units were distributed in New Jersey, as well as in Germany, Croatia, Italy, India, Poland, and Spain. Healthcare providers and facilities should check their inventory for this specific lot number and stop using the product if found.
The recalled product
- Product
- Covidien CV-9590 Velosorb Fast Braided Fast absorbable Suture 14 Metric 36" 90 cm, GS-24 Taper 1/2 40 mm, undyed, UDI: 10884521151307
- Manufacturer
- Riverpoint Medical, LLC
- Category
- Medical Device — Sutures
- Affected units
- 3,060
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot # 19062715X
Distribution
Distributed in 1 state:
Related recalls
Same manufacturer · Riverpoint Medical, LLC
See all →- HighIconix Knotless 1.4mm Anchor recalled due to inserter failure risk
FDA (Devices) · 2023-12-20
- HighRiverpoint Recalls Non-Sterile Velosorb Surgical Sutures
FDA (Devices) · 2020-10-07
- HighRiverpoint Medical Recalls Non-Sterile Velosorb Surgical Sutures
FDA (Devices) · 2020-10-07
- SevereRiverpoint Recalls Non-Sterile Velosorb Surgical Sutures
FDA (Devices) · 2020-10-07
- HighRiverpoint Medical Recalls Non-Sterile Velosorb Surgical Sutures
FDA (Devices) · 2020-10-07