Medline recallZ-1358-2020 · Medline Industries Inc · initiated Jan 21, 2020
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medline Industries Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-1358-2020
- Status
- Terminated
- Initiated by the company
- Jan 21, 2020
- Posted by the FDA
- Feb 11, 2020
- Recalling firm
- Medline Industries Inc
- Quantity
- 122
- Product code
- FDE
- 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
Product description
Medline ROBOTIC-LF REF CDS984543B Lot 20AKA927 Expiration 2020-09-30 GTIN (01)10888277056350
Code information (models, lots, serial numbers)
REF CDS984543B Lot 20AKA927 Expiration 2020-09-30 GTIN (01)10888277056350
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Medline Industries, Inc. CDS984543BMedline Industries, Inc. · laparoscopy kit1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 84908).
- Z-1357-2020 · TerminatedMedline HOI LUMBAR REF DYNJ902823G Lot 20AKA895 Expiration 2021-05-31 1 each GTIN (01)10193489219180
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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