CLASS II Device recall · Reported 10 Feb 2021 · FDA Enforcement Report
Covidien CV-9590 Velosorb Fast Braided Fast absorbable recalled
Riverpoint Medical is recalling Covidien CV-9590 Velosorb Fast Braided Fast absorbable Suture 14 Metric 36", GS-24 Taper, distributed in New Jersey. The recall was initiated on 9 Dec 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0949-2021
- FDA event ID
- 87036
- Recalling firm
- Riverpoint Medical, Portland, OR
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Dec 2020
- FDA classified
- 3 Feb 2021
- Reported
- 10 Feb 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Surgical Instruments
Timeline
| 9 Dec 2020 | Recall initiated by company | |
| 3 Feb 2021 | Classified by FDA | +56 days |
| 10 Feb 2021 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to a manufacturing error, there is a potential that sutures may exhibit inadequate tensile strength. This could potentially lead to intra-operative and post-operative complications such as suture break or wound dehiscence.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
Covidien CV-9590 Velosorb Fast Braided Fast absorbable Suture 14 Metric 36" 90 cm, GS-24 Taper 1/2 40 mm, undyed, UDI: 10884521151307
Where it was distributed
US: NJ OUS: Germany, Croatia, Italy, India, Poland and Spain.
Stores named: Walmart
Questions about this recall
Is Covidien CV-9590 Velosorb Fast Braided Fast absorbable Suture 14 Metric 36", GS-24 Taper recalled?
Yes. Riverpoint Medical recalled Covidien CV-9590 Velosorb Fast Braided Fast absorbable Suture 14 Metric 36", GS-24 Taper on 9 Dec 2020. The recall is Class II and its status is Terminated. Recall number Z-0949-2021.
Why was it recalled?
Due to a manufacturing error, there is a potential that sutures may exhibit inadequate tensile strength. This could potentially lead to intra-operative and post-operative complications such as suture break or wound dehiscence.
Which lots are affected?
Lot # 19062715X
Where was it sold?
US: NJ OUS: Germany, Croatia, Italy, India, Poland and Spain.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Riverpoint Medical
All 47| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Iconix Knotless Anchor with XBraid S (Blue/Black) recalled | Riverpoint Medical | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Velosorb Fast Braided Absorbable Suture recalled by Riverpoint Medical | Riverpoint Medical | Sterility | Nationwide |
| Device | CLASS II | Velosorb Fast Braided Absorbable Suture recalled by Riverpoint Medical | Riverpoint Medical | Sterility | Nationwide |
| Device | CLASS II | Velosorb Fast Braided Absorbable Suture recalled by Riverpoint Medical | Riverpoint Medical | Sterility | Nationwide |
| Device | CLASS II | Velosorb Fast Braided Absorbable Suture recalled by Riverpoint Medical | Riverpoint Medical | Sterility | Nationwide |
Other Surgical Instruments recalls
All 3,809| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: IV Start KIT recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled | ConMed | Sterility | Nationwide |