Z-3128-2024Class II

Medtronic DLP Single Stage Venous Cannulae with right angle metal tip, REF 67312

Name: Z-3128-2024 Medtronic DLP Single Stage Venous Cannulae with right angle metal tip, REF 67312
Creator: Medtronic Perfusion Systems
Published: 2024-07-09
License: https://open.fda.gov/license/

Medtronic Perfusion Systems / initiated 2024-07-09 / Open, Classified / root cause: labeling and UDI

FDA source

Medtronic Perfusion Systems began a recall of Medtronic DLP Single Stage Venous Cannulae with right angle metal tip, REF 67312 on 2024-07-09. FDA classified it as Class II and gives the reason as "During manufacturing, DLP Single Stage Venous Cannulae - straight tip (Model 66118) was incorrectly placed into a product labeled as DLP Single Stage Venous Cannulae - right angle metal tip (Model 67312)". 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-3128-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-07-09
Posted: 2024-09-12
Recalling firm: Medtronic Perfusion Systems
Product: Medtronic DLP Single Stage Venous Cannulae with right angle metal tip, REF 67312
Product code: DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Reason for recall: During manufacturing, DLP Single Stage Venous Cannulae - straight tip (Model 66118) was incorrectly placed into a product labeled as DLP Single Stage Venous Cannulae - right angle metal tip (Model 67312).
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: Medtronic issued an Urgent: Medical Device Recall notice to its consignees on 07/09/2024 via UPS. The notice explained the issue, potential risk, and requested return of the affected device. Those who further distributed the device were directed to share the notice with those to whom the affected product was distributed.
Quantity in commerce: 290 units
Distribution: Worldwide distribution - US Nationwide and the countries of Cambodia, Greece, Ireland, Italy, Saudi Arabia, Switzerland, United Kingdom, Viet Nam.
Product codes and lots: GTIN 20613994879329, Lot Numbers: 2023090954, 202312C065

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3128-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3128-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-18	2024-09-12

Product code DWF

K120988Class IIDlp Single Stage Venous Cannula, Dlp Right Angle Single Stage Venous Cannula, Dlp Single Stage Venous Cannula with RightMedtronic, Inc. / cleared 2012-07-25

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)