Z-1132-2022Class II

Surgical Suture Kit

Name: Z-1132-2022 Surgical Suture Kit
Creator: Stradis Healthcare
Published: 2022-04-22
License: https://open.fda.gov/license/

Gyn-Disposables, Inc. / initiated 2022-04-22 / Open, Classified / root cause: packaging

FDA source

Stradis Healthcare began a recall of Surgical Suture Kit on 2022-04-22. FDA classified it as Class II and gives the reason as "There is uncertainty about the integrity of the methods used to ensure the sterile barrier integrity". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1132-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-04-22
Posted: 2022-05-25
Recalling firm: Gyn-Disposables, Inc.
Product: Surgical Suture Kit
Product code: MCZ Suture Removal Kit
Reason for recall: There is uncertainty about the integrity of the methods used to ensure the sterile barrier integrity.
Root cause tag: packaging
FDA root cause: Under Investigation by 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.
Quantity in commerce: 7340 units
Distribution: US Distribution to NC.
Product codes and lots: Part Number: ZZ-0958; Primary DI Number: M752ZZ09580; Lot Numbers: 213639474, 212957814, 212675717

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1132-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1132-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-06-01	2022-05-25

Product code MCZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)