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Terminated

Surgical Suture Kit

FDA Recall Z-1132-2022 · Posted None

Recalling FirmStradis Healthcare
Recall StatusTerminated
Product CodeMCZ
Date Initiated2022-04-22
Date Terminated2026-09-22
Product Quantity7340 units

Reason for Recall

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

Firm Action

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 [email protected]. 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.

Root Cause

Under Investigation by firm

Distribution Pattern

US Distribution to NC.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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