CLASS II Device recall · Reported 7 Oct 2020 · FDA Enforcement Report
Velosorb Fast Braided Absorbable Suture recalled by Riverpoint Medical
Riverpoint Medical is recalling Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" GS-11 Cutting, distributed nationwide in the US. The recall was initiated on 3 Aug 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-0037-2021
- FDA event ID
- 86254
- Recalling firm
- Riverpoint Medical, Portland, OR
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Aug 2020
- FDA classified
- 1 Oct 2020
- Reported
- 7 Oct 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 3 Aug 2020 | Recall initiated by company | |
| 1 Oct 2020 | Classified by FDA | +59 days |
| 7 Oct 2020 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" GS-11 Cutting CV4731, UDI: 20884521151359 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
Where it was distributed
US Nationwide distribution.
Questions about this recall
Is Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" GS-11 Cutting recalled?
Yes. Riverpoint Medical recalled Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" GS-11 Cutting on 3 Aug 2020. The recall is Class II and its status is Terminated. Recall number Z-0037-2021.
Why was it recalled?
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
Which lots are affected?
Lot Number: 20060204X
Where was it sold?
US Nationwide distribution.
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 | Covidien CV-9590 Velosorb Fast Braided Fast absorbable recalled | Riverpoint Medical | Lead & Heavy Metals | NJ |
| 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 Heart & Vascular Devices recalls
All 6,190| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Presource Packs Containing CliniClean Pericare Wipes within recalled | Cardinal Health 200 | Other | Nationwide |
| Device | CLASS II | Presource Packs Containing CliniClean Pericare Wipes within recalled | Cardinal Health 200 | Other | Nationwide |
| Device | CLASS II | Presource Packs Containing CliniClean Pericare Wipes within recalled | Cardinal Health 200 | Other | Nationwide |
| Device | CLASS II | Presource Packs Containing CliniClean Pericare Wipes within recalled | Cardinal Health 200 | Other | Nationwide |
| Device | CLASS II | Presource Packs Containing CliniClean Pericare Wipes within recalled | Cardinal Health 200 | Other | Nationwide |