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U.S. Department of Health and Human Services

Class 2 Device Recall Stradis

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 Class 2 Device Recall Stradissee related information
Date Initiated by FirmApril 22, 2022
Create DateMay 25, 2022
Recall Status1 Open3, Classified
Recall NumberZ-1132-2022
Recall Event ID 90059
Product Classification Suture removal kit - Product Code MCZ
ProductSurgical Suture Kit
Code Information Part Number: ZZ-0958; Primary DI Number: M752ZZ09580; Lot Numbers: 213639474, 212957814, 212675717
Recalling Firm/
Manufacturer		 Stradis Healthcare
3600 Burwood Dr
Waukegan IL 60085-8399
For Additional Information ContactPhil Toblin
847-596-7740
Manufacturer Reason
for Recall		There is uncertainty about the integrity of the methods used to ensure the sterile barrier integrity.
FDA Determined
Cause 2		Under Investigation by firm
ActionThe 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 in Commerce7340 units
DistributionUS Distribution to NC.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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