Z-1358-2020Class II

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

Name: Z-1358-2020 Medline ROBOTIC-LF REF CDS984543B Lot 20AKA927 Expiration 2020-09-30 GTIN (01)10888277056350
Creator: Medline Industries Inc
Published: 2020-01-21
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2020-01-21 / Terminated / root cause: sterility

FDA source

Medline Industries Inc began a recall of Medline ROBOTIC-LF REF CDS984543B Lot 20AKA927 Expiration 2020-09-30 GTIN (01)10888277056350 on 2020-01-21. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1358-2020
Classification: Class II
Status: Terminated
Initiated: 2020-01-21
Posted: 2020-02-11
Terminated: 2023-01-12
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Medline ROBOTIC-LF REF CDS984543B Lot 20AKA927 Expiration 2020-09-30 GTIN (01)10888277056350
Product code: FDE Laparoscopy Kit
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.
Root cause tag: sterility
FDA 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 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
Product codes and lots: REF CDS984543B Lot 20AKA927 Expiration 2020-09-30 GTIN (01)10888277056350

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1358-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1357-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-04	2020-02-25
Z-1358-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-04	2020-02-25

Product code FDE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)