Z-0360-2022Class II

Major Vascular CDS Convenience Kit

Name: Z-0360-2022 Major Vascular CDS Convenience Kit
Creator: Medline Industries Inc
Published: 2021-10-27
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2021-10-27 / Terminated

FDA source

Medline Industries Inc began a recall of Major Vascular CDS Convenience Kit on 2021-10-27. FDA classified it as Class II and gives the reason as "NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0360-2022
Classification: Class II
Status: Terminated
Initiated: 2021-10-27
Posted: 2021-12-10
Terminated: 2023-04-05
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Major Vascular CDS Convenience Kit
Product code: LRO General Surgery Tray
Reason for recall: NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020.
FDA root cause: Incorrect or no expiration date
Action: Medline Industries, Inc. is recalling specific convenience kits containing the Baxter NaCl 250mL Bag Inj due to the Baxter NaCl 250mL Bag Inj expiring April 2020. No other components within these packs are affected and can continue to be used. Our records indicate that these Baxter NaCl 250mL Bag Inj were used as a component in the attached list of kit(s) purchased from Medline Industries, Inc. 1. Immediately check your stock for the specific kit number and the affected kit lot number in the attached list. Quarantine any kits with the listed lot numbers. If you don t have any of the lots listed above skip to step 3. 2. Affix the enclosed stickers on the affected kits and return to stock. If additional stickers are needed please call 866-359-1704. Please be sure NOT to use the Baxter NaCl 250mL Bag Inj components, pull another approved product from sterile supply. 3. Please fill out and return the enclosed Verification Form via email to [email protected] or fax 866-767-1290. Note: By signing and returning the Verification Form you acknowledge that you received and understand this notification.
Quantity in commerce: 15
Distribution: US Nationwide distribution.
Product codes and lots: Model #: CDS981543D Lot #: 19HBK745 UDI: GTIN (01)4088277523976 EXP (17)2021-07-31 LOT (10)19HBK745

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0360-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0358-2022	Class II	Terminated	Voluntary: Firm initiated	2021-12-22	2021-12-10
Z-0359-2022	Class II	Terminated	Voluntary: Firm initiated	2021-12-22	2021-12-10
Z-0360-2022	Class II	Terminated	Voluntary: Firm initiated	2021-12-22	2021-12-10
Z-0361-2022	Class II	Terminated	Voluntary: Firm initiated	2021-12-22	2021-12-10
Z-0362-2022	Class II	Terminated	Voluntary: Firm initiated	2021-12-22	2021-12-10

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)