Z-2135-2023Class II

MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: HYSTERO PACK, Model Number DYNJ61448A

Name: Z-2135-2023 MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: HYSTERO PACK, Model Number DYNJ61448A
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2023-05-18
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2023-05-18 / Open, Classified / root cause: manufacturing process

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: HYSTERO PACK, Model Number DYNJ61448A on 2023-05-18. FDA classified it as Class II and gives the reason as "Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON-STERILE PVP SOLUTION, STERILE PACKAGING"". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2135-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-05-18
Posted: 2023-07-12
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: HYSTERO PACK, Model Number DYNJ61448A
Product code: LRO General Surgery Tray
Reason for recall: Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON-STERILE PVP SOLUTION, STERILE PACKAGING".
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Medline issued a recall notice on 06/02/2023 to its consignees via USPS first class mail. The notice explained the problem with the product and requested the destruction of the product. Medline identified additional products, lots, and consignees and notified their consignees by email on 06/09/2023. Upon receipt of the submitted response form each account will receive over-labels to affix to the affected kits via FedEx overnight, if applicable. distributors were directed to notify their customers and collect the returned product and return it to Medline.
Quantity in commerce: 60 units
Distribution: Worldwide distribution - US Nationwide and the country of Panama.
Product codes and lots: UDI/DI (EA) (01)10193489799477, UDI/DI (01)40193489799478; Lot Numbers: 23CBS268

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2135-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2131-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-19	2023-07-12
Z-2132-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-19	2023-07-12
Z-2133-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-19	2023-07-12
Z-2134-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-19	2023-07-12
Z-2135-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-19	2023-07-12
Z-2136-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-19	2023-07-12
Z-2137-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-19	2023-07-12

Product code LRO

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)