Surgical Suture Kit
This recall is currently active, issued April 22, 2022. It was issued by Stradis Healthcare.
- Company
- Stradis Healthcare
- Recall Initiated
- April 22, 2022
- Recall Number
- Z-1132-2022
- Quantity
- 7340 units
- Firm Location
- Waukegan, IL
- Official Source
- View on FDA website ↗
Reason for Recall
There is uncertainty about the integrity of the methods used to ensure the sterile barrier integrity.
Distribution
US Distribution to NC.
Lot / Code Info
Part Number: ZZ-0958; Primary DI Number: M752ZZ09580; Lot Numbers: 213639474, 212957814, 212675717
Root Cause
Under Investigation by firm
Action Taken
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.