Surgical Suture Kit

Date

June 1, 2022

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Terminated

Filed by

Stradis Healthcare

Product

Surgical Suture Kit

Reason

There is uncertainty about the integrity of the methods used to ensure the sterile barrier integrity.

Distribution pattern

US Distribution to NC.

Quantity

7340 units

Codes and lots

Part Number: ZZ-0958; Primary DI Number: M752ZZ09580; Lot Numbers: 213639474, 212957814, 212675717

Recall started

April 22, 2022

Device type

Suture Removal Kit

Root cause (FDA)

Under Investigation by firm

What the company told customers

The firm, Stradis Health, initiated an "URGENT: MEDICAL DEVICE RECALL" on 04/22/2022 via email. The letter instructs the consignee to examine your inventory and immediately quarantine any affected product; contact Stradis Customer Service to arrange or return, shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Service can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. Notify their customer within 48 hours and the customers should contact the firm to arrange for a return. The firm is also requesting that the consignees return an acknowledgement form. If you have any questions regarding this notification, please do not hesitate to contact us at 1-800-886-7257.

Recall number

Z-1132-2022

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-1132-2022. The agency record governs; check it and the company before acting.