Z-0034-2021Class II

Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 1 Undyed 36" GS-25, Product Number: CV605, UDI...

Name: Z-0034-2021 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 1 Undyed 36" GS-25, Product Number: CV605, UDI...
Creator: Riverpoint Medical, LLC
Published: 2020-08-03
License: https://open.fda.gov/license/

Riverpoint Medical, LLC / initiated 2020-08-03 / Terminated / root cause: sterility

FDA source

Riverpoint Medical, LLC began a recall of Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 1 Undyed 36" GS-25, Product Number: CV605, UDI: 20884521152295 - Product Usage: indicated for use in... on 2020-08-03. FDA classified it as Class II and gives the reason as "The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0034-2021
Classification: Class II
Status: Terminated
Initiated: 2020-08-03
Posted: 2020-10-01
Terminated: 2022-09-08
Recalling firm: Riverpoint Medical, LLC
Product: Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 1 Undyed 36" GS-25, Product Number: CV605, UDI: 20884521152295 - 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.
Product code: GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
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.
Root cause tag: sterility
FDA root cause: Under Investigation by firm
Action: On 08/03/2020, the firm notified affected customer via email using a letter titled, "URGENT: MEDICAL DEVICE RECALL" indicating that the customer should do the following: - Immediately examine inventory and quarantine product subject to the recall. - Discontinue selling product listed above and return any existing stock to the firm. - Complete and return the enclosed response form as soon as possible via email. Mark the return shipments with the RGA number. - Provide recall information to any customers to whom you may have distributed or forwarded affected product. Customer may include a copy of this recall notice with your customer notification. If you have any questions, call the firm at (503) 517-8001.
Quantity in commerce: 1811
Distribution: US Nationwide distribution.
Product codes and lots: Lot Number: 20060201X

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0034-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0010-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-07	2020-10-01
Z-0011-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-07	2020-10-01
Z-0012-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-07	2020-10-01
Z-0013-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-07	2020-10-01
Z-0014-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-07	2020-10-01
Z-0015-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-07	2020-10-01
Z-0016-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-07	2020-10-01
Z-0017-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-07	2020-10-01
Z-0018-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-07	2020-10-01
Z-0019-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-07	2020-10-01
Z-0020-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-07	2020-10-01
Z-0021-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-07	2020-10-01
Z-0022-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-07	2020-10-01
Z-0023-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-07	2020-10-01
Z-0024-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-07	2020-10-01
Z-0025-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-07	2020-10-01
Z-0026-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-07	2020-10-01
Z-0027-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-07	2020-10-01
Z-0028-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-07	2020-10-01
Z-0029-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-07	2020-10-01
Z-0030-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-07	2020-10-01
Z-0031-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-07	2020-10-01
Z-0032-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-07	2020-10-01
Z-0033-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-07	2020-10-01
Z-0034-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-07	2020-10-01
Z-0035-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-07	2020-10-01
Z-0036-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-07	2020-10-01
Z-0037-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-07	2020-10-01
Z-0038-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-07	2020-10-01
Z-0039-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-07	2020-10-01
Z-0040-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-07	2020-10-01
Z-0041-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-07	2020-10-01
Z-0042-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-07	2020-10-01
Z-0043-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-07	2020-10-01
Z-0044-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-07	2020-10-01
Z-0045-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-07	2020-10-01
Z-0046-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-07	2020-10-01
Z-0047-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-07	2020-10-01
Z-0048-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-07	2020-10-01
Z-0049-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-07	2020-10-01

Product code GAM

K120556Class IIVilet Vilet QuickRiverpoint Medical / cleared 2012-05-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)