Z-0167-2023Class II

CENTURION MEDICAL PRODUCTS NICU PICC INSERTION BUNDLE W/O, REF CVI4470. Convenience kit used in medical...

Name: Z-0167-2023 CENTURION MEDICAL PRODUCTS NICU PICC INSERTION BUNDLE W/O, REF CVI4470. Convenience kit used in medical...
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2022-09-30
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2022-09-30 / Open, Classified / root cause: packaging

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of CENTURION MEDICAL PRODUCTS NICU PICC INSERTION BUNDLE W/O, REF CVI4470. Convenience kit used in medical procedures on 2022-09-30. FDA classified it as Class II and gives the reason as "Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0167-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-09-30
Posted: 2022-11-01
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: CENTURION MEDICAL PRODUCTS NICU PICC INSERTION BUNDLE W/O, REF CVI4470. Convenience kit used in medical procedures.
Product code: LRP Tray, Surgical
Reason for recall: Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: Medline disseminated MEDICAL DEVICE RECALL notice by US mail on 09/30/2022, The notices explained the issue and requested the following: "REQUIRED ACTION: 1.Immediately check your stock for the affected item number and the affected lot numbers listed on the recall portal. Destroy affected product. 2.Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the form. The login for completing the response form is: Website link: https://recalls.medline.com Recall Reference #: R-22-149-FG Recall Code: RXXXXXXX 3.Upon completion of the form, please destroy affected product. Your account will receive credit once the response form is submitted. 4.If you are a distributor, or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Have the customers document and destroy any affected product. You should include your customers quantities on your response form. If you have any questions, please contact the Recall Department at 866-359-1704."
Quantity in commerce: 50 kits
Distribution: US Nationwide distribution in the states of CA, MN, NC, NY, OK, PA, TN, TX.
Product codes and lots: GTIN (01) 40653160316252, Lot Number 21KBB343

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0167-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0155-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-09	2022-11-01
Z-0156-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-09	2022-11-01
Z-0157-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-09	2022-11-01
Z-0158-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-09	2022-11-01
Z-0159-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-09	2022-11-01
Z-0160-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-09	2022-11-01
Z-0161-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-09	2022-11-01
Z-0162-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-09	2022-11-01
Z-0163-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-09	2022-11-01
Z-0164-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-09	2022-11-01
Z-0165-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-09	2022-11-01
Z-0166-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-09	2022-11-01
Z-0167-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-09	2022-11-01

Product code LRP

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)