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Recall Observatory FDA recall evidence

Device product

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

Z-3128-2024

July 09, 2024

Class II

Product summary

Firm
Medtronic Perfusion Systems
Event
Event 95152
Status
Ongoing
Classification
Class II
Quantity
290 units
Official record key
device-enforcement:Z-3128-2024

Official wording

Reason: 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).

Code information: GTIN 20613994879329, Lot Numbers: 2023090954, 202312C065

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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).