Recall Z-1358-2020 ยท FDE Laparoscopy Kit
Medline Industries Inc
Medline ROBOTIC-LF REF CDS984543B Lot 20AKA927 Expiration 2020-09-30 GTIN (01)10888277056350
| Date | Feb 11, 2020 (initiated Jan 21, 2020) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.