Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Medline ROBOTIC-LF REF CDS984543B Lot 20AKA927 Expiration 2020-09-30 GTIN (01)10888277056350

FDA Recall Z-1358-2020 · Posted 2020-02-11

Recalling FirmMedline Industries Inc
Recall StatusTerminated
Product CodeFDE
Date Initiated2020-01-21
Date Terminated2023-01-12
Product Quantity122

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.

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.

Root Cause

Under Investigation by firm

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑