FDA Medical Device Recalls (openFDA)
Stradis Healthcare: Surgical Suture Kit
- Recall number
- Z-1132-2022
- Recalling firm
- Stradis Healthcare
- Product
- Surgical Suture Kit
- Status
- Open, Classified
- Initiated
- 2022-04-22
- Posted
- not on file
- Terminated
- not on file
- Reason
- There is uncertainty about the integrity of the methods used to ensure the sterile barrier integrity.
- 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 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.
- Quantity
- 7340 units
- Distribution
- US Distribution to NC.
- Lot, serial or model codes
- Part Number: ZZ-0958; Primary DI Number: M752ZZ09580; Lot Numbers: 213639474, 212957814, 212675717
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MCZ
- Firm FEI
- 1450943
- Firm city
- Waukegan
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28