RecallRadar

FDA Device recall Z-0949-2021

Covidien CV-9590 Velosorb Fast Braided Fast absorbable Suture 14 Metric 36" 90 cm, GS-24 Taper 1/2 40 mm, undyed, UDI: 10884521151307

On 2021-02-10 the FDA classified a Class II recall of Covidien CV-9590 Velosorb Fast Braided Fast absorbable Suture 14 Metric 36" 90 cm, GS-24 Taper 1/2 40 mm, undyed, UDI: 10884521151307 by Riverpoint Medical, citing 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 complica….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0949-2021
ClassificationClass II
Statusterminated
Initiated2020-12-09
Published2021-02-10
Last updated2026-09-13 11:56 UTC
CompanyRiverpoint Medical
DistributionNJ

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

Reason

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.

Identifiers

code_infoLot # 19062715X

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.

Other recalls by Riverpoint Medical

All Riverpoint Medical recalls

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0949-2021%22

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