RecallRadar

FDA Device recall Z-1802-2024

Medtronic Disposable Pressure Display Sets: a) DLP¿ 114.3 cm (45 in), Model Number 61000

On 2024-05-22 the FDA classified a Class II recall of Medtronic Disposable Pressure Display Sets: a) DLP¿ 114.3 cm (45 in), Model Number 61000 by Medtronic Perfusion Systems, citing potential for unsealed sterile packing.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1802-2024
ClassificationClass II
Statusongoing
Initiated2024-03-19
Published2024-05-22
Last updated2026-09-13 11:57 UTC
CompanyMedtronic Perfusion Systems
Distributionn/a

Product

Medtronic Disposable Pressure Display Sets: a) DLP¿ 114.3 cm (45 in), Model Number 61000; b) DLP¿ 114.3 cm (45 in), Model Number 62000

Reason

Potential for unsealed sterile packing.

Identifiers

code_info
a) Model Number 61000, GTIN 00643169880955, Lot Numbers: 2023030432, 2023030433; a) Model Number 61000, GTIN 2064316…a) Model Number 61000, GTIN 00643169880955, Lot Numbers: 2023030432, 2023030433; a) Model Number 61000, GTIN 20643169880959, Lot Numbers: 2023030431, 2023030432, 2023030433, 2023030734, 202305C226, 202307C176, 202307C177; b) Model Number 62000, GTIN 20613994846642, Lot Numbers: 2023030223, 2023030736, 2023031580, 202305C225

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1802-2024%22

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