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U.S. Department of Health and Human Services

Class 2 Device Recall ROBOTICLF Surgical procedure kit

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  Class 2 Device Recall ROBOTICLF Surgical procedure kit see related information
Date Initiated by Firm January 21, 2020
Date Posted February 11, 2020
Recall Status1 Terminated 3 on January 12, 2023
Recall Number Z-1358-2020
Recall Event ID 84908
Product Classification laparoscopy kit - Product Code FDE
Product Medline
ROBOTIC-LF
REF CDS984543B
Lot 20AKA927 Expiration 2020-09-30
GTIN (01)10888277056350
Code Information REF CDS984543B Lot 20AKA927 Expiration 2020-09-30 GTIN (01)10888277056350
Recalling Firm/
Manufacturer		 Medline Industries Inc
Three Lakes Drive
Northfield IL 60093
For Additional Information Contact Kassandra Cotner
866-359-1704
Manufacturer Reason
for Recall		 The sterile pack inside the Complete Delivery System (CDS) did not go through a complete sterilization cycle, therefore the sterility of these components cannot be guaranteed.
FDA Determined
Cause 2		 Under Investigation by firm
Action Consignees were notified by telephone on 01/21/2020 followed by an e-mail on 01/22/2020 and 02/05/2020 that included a formal recall letter with response form. The recall letter identified the affected product and requested the user to quarantine the product for subsequent pick up by Medline Industries Inc. Consignee was asked to complete and return Recall Response form.
Quantity in Commerce 122
Distribution California only. No governmental, Canadian or Mexican consignees. TORRANCE MEMORIAL MEDICAL 3105 LOMITA BLVD TORRANCE CA 905055108 HOAG MEMORIAL HOSPITAL 1 HOAG DR NEWPORT BEACH CA 926634162 OWENS/MINORVMI TEM (65) 5125 ONTARIO MILLS PKWY ONTARIO CA 917645103
Total Product Life Cycle TPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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