Z-1048-2025Class II

CENTURION Infusion Catheter, 7F, 17cm (DO), Reorder MIC17F7; Infusion Catheter with Antimicrobial Heparin...

Name: Z-1048-2025 CENTURION Infusion Catheter, 7F, 17cm (DO), Reorder MIC17F7; Infusion Catheter with Antimicrobial Heparin...
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2024-12-23
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2024-12-23 / Open, Classified / root cause: labeling and UDI

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of CENTURION Infusion Catheter, 7F, 17cm (DO), Reorder MIC17F7; Infusion Catheter with Antimicrobial Heparin Coating on 2024-12-23. FDA classified it as Class II and gives the reason as "Certain lots Sterile Infusion Catheters which were mislabeled as having a heparin coating were either distributed or manufactured into medical convenience kits and distributed". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1048-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-12-23
Posted: 2025-01-29
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: CENTURION Infusion Catheter, 7F, 17cm (DO), Reorder MIC17F7; Infusion Catheter with Antimicrobial Heparin Coating.
Product code: DYB Introducer, Catheter
Reason for recall: Certain lots Sterile Infusion Catheters which were mislabeled as having a heparin coating were either distributed or manufactured into medical convenience kits and distributed.
Root cause tag: labeling and UDI
FDA root cause: Process change control
Action: Medline Industries, LP issued one IMMEDIATE ACTION REQUIRED notice and one MEDICAL DEVICE RECALL notice to its affected consignees on 12/23/2024 via email and US Mail. The IMMEDIATE ACTION REQUIRED notice explained the labeling issue with the device, potential risk, and requested the following actions be taken: 1. affected catheters be quarantined, 2. respond with quantity on hand, 3. if the product was transferred to notify those to whom the affected catheters were transferred. Upon receipt of the response. Medline will issue corrected labeling to affix to the devices. The MEDICAL DEVICE RECALL notice, which pertains to kits manufactured with the affected catheters as a component, also explained the labeling issue with the device, potential risk, and requested the following actions be taken: 1. affected catheters be quarantined, 2. respond with quantity on hand, 3. if the product was transferred to notify those to whom the affected catheters were transferred. Upon receipt of the response. Medline will issue a label to affix to the devices which will state the affected component shall be removed and discarded from further use.
Quantity in commerce: 1200 units
Distribution: US: FL, KS, ND, PA, WA, WV, IL, WA
Product codes and lots: UDI/DI 10653160249979 (EA) 20653160249976 (CS), Lot Numbers: 2024103190, 2024050990, 2024021290, 2024012990, 2024111990

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1048-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1048-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-05	2025-01-29
Z-1049-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-05	2025-01-29

Product code DYB

K885179Class IIIntro-Flex Sheath Introducer W/amc ThromboshieldBaxter Healthcare Corp / cleared 1989-08-09

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)