FDA Device Recall Z-0038-2021: Riverpoint Medical, LLC

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0038-2021.

Recall Res Number

Z-0038-2021

Recalling Firm / Manufacturer

Riverpoint Medical, LLC

FEI Number

3006981798

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2020-08-03

Date Posted

N/A

Date Terminated

2022-09-08

Product Code

GAM

Event Number

86254

Product Quantity

1260

Product Description Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" P-11 SVP2295, UDI: 20884521177410 - 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.

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.

Action Details 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.

Distribution Pattern US Nationwide distribution.

Code Information / Serial Numbers Lot Number: 20060205FX

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Medical Device Recall: Z-0038-2021

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer