Z-2978-2018Class II

Laparoscopy CDS

Name: Z-2978-2018 Laparoscopy CDS
Creator: Medline Industries, Inc.
Published: 2017-04-12
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2017-04-12 / Terminated / root cause: labeling and UDI

FDA source

Medline Industries, Inc. began a recall of Laparoscopy CDS on 2017-04-12. FDA classified it as Class II and gives the reason as "One manufacturing lot of a non-sterile pack was assembled with a non-sterile component labeled sterile (kit component #80532NS). The non-sterile component 80532NS was supposed to be placed inside the sterile portion of...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2978-2018
Classification: Class II
Status: Terminated
Initiated: 2017-04-12
Posted: 2018-09-06
Terminated: 2019-08-05
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Laparoscopy CDS
Product code: N/A
Reason for recall: One manufacturing lot of a non-sterile pack was assembled with a non-sterile component labeled sterile (kit component #80532NS). The non-sterile component 80532NS was supposed to be placed inside the sterile portion of the pack where it would subsequently be exposed to the ethylene oxide sterilization process. However, the component was not placed in the sterile portion of the pack during assembly and was never exposed to the sterilization process. Component 80532NS was inadvertently released non-sterile. Component 80532NS is packaged by Medline and is an Anti-fog kit that contains 1 bottle of 6g Anti-Fog solution and an adhesive backed sponge.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: Firm contacted customers via phone and letter beginning April 12, 2017. Customers were instructed to remove the Ethicon BioPatch Protective Disk with CHG from the kit(s) and return it to the firm. The firm would provide a sterile replacement BioPatch. Affected product will be destroyed.
Quantity in commerce: 15 kits
Distribution: CA, NM
Product codes and lots: Model: CDS920114F. Lot: 17MB5499

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2978-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2976-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-12	2018-09-06
Z-2977-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-12	2018-09-06
Z-2978-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-12	2018-09-06
Z-2979-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-12	2018-09-06
Z-2980-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-12	2018-09-06

Product code N/A

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)