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Open, Classified

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

FDA Recall Z-3128-2024 · Posted 2024-09-12

Recalling FirmMedtronic Perfusion Systems
Recall StatusOpen, Classified
Product CodeDWF
Date Initiated2024-07-09
Product Quantity290 units

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).

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.

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Cambodia, Greece, Ireland, Italy, Saudi Arabia, Switzerland, United Kingdom, Viet Nam.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K120988DLP SINGLE STAGE VENOUS CANNULA, DLP RIGHT ANGLE SINGLE STAGE VENOUS CANNULA, DLP SINGLE STAGE VENOUS CANNULA WITH RIGHTMedtronic, Inc. · 2012-07-25

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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