Medline ROBOTIC-LF REF CDS984543B Lot 20AKA927 Expiration 2020-09-30 GTIN (01)10888277056350
FDA device recall Z-1358-2020 · posted 2020-02-11 · Terminated
Recall details
- Recalling firm
- Medline Industries Inc
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- FDE
- Quantity affected
- 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/MIN
- Date initiated
- 2020-01-21
- Date posted
- 2020-02-11
- Date terminated
- 2023-01-12
- Location
- Northfield, IL
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