FDAClass IINovember 6, 2024

Lifepak 15 recall

LIFEPAK 15 (LP15) Model/Catalog Numbers: o 97577-000101 o 99577-000046 o 99577-000055 o 99577-000061 o 99577-000076 o 99577-001250 o 99577-001255 o…

Why was Lifepak 15 recalled?

Due to an out of tolerance tool being used on monitor/defibrillator systems.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

LIFEPAK 15 (LP15) Model/Catalog Numbers: o 97577-000101 o 99577-000046 o 99577-000055 o 99577-000061 o 99577-000076 o 99577-001250 o 99577-001255 o 99577-001256 o 99577-001368 o 99577-001955 o 99577-001956 o 99577-001957 o 99577-001958 o 99577-001962 UDI-DI codes: o 00883873808214 o 00883873988022 o 00883873979426 o 00883873979358 o 00883873911693 o 00883873979198 o 00883873911648 o 00883873884386 o 00883873871713 o 00883873871706 o 00883873871690 o 00883873871683 o 00883873911631 o 00883873871645 Serial Numbers: o 45435833 o 46470647 o 46686048 o 46686573 o 46686708 o 46687360 o 46906073 o 49037777 o 49704552 o 38166647 o 38282988 o 38290136 o 38291331 o 38802782 o 39541663 o 39541666 o 39752193 o 40259639 o 41446867 o 41447020 o 41453331 o 42325059 o 43574409 o 43984215 o 45040678 o 45308104 o 45455023 o 46017745 o 46572054 o 46576300 o 48349664 o 48605645 o 48605663 o 49001744 o 49025185 o 49070762 o 49087040 o 49087053 o 49224619 o 49374174 o 49422314 o 49619921 o 38200440 o 38805564 o 38805583 o 39382735 o 41446693 o 41446882 o 41446975 o 41446977 o 41447027 o 41453239 o 41893891 o 42324176 o 42610924 o 43181935 o 43182268 o 43182389 o 43462227 o 43465372 o 43487806 o 43610792 o 43791346 o 43841374 o 43860850 o 43862247 o 43869747 o 44169862 o 44356379 o 44360003 o 44601246 o 45590467 o 45907317 o 46364496 o 46691551 o 47447195 o 47515791 o 47539203 o 47539310 o 47785570 o 47794250 o 48524850 o 48583111 o 48585709 o 48600317 o 48605407 o 48605467 o 48704914 o 48749443 o 49022830 o 49031342 o 49036187 o 49056308 o 49057928 o 49123367 o 49126651 o 49127012 o 49132399 o 49132740 o 49134638 o 49511402 o 49513814

Product
LIFEPAK 15 (LP15) Model/Catalog Numbers: o 97577-000101 o 99577-000046 o 99577-000055 o 99577-000061 o 99577-000076 o 99577-001250 o 99577-001255 o…
Recalling firm
Physio-Control, Inc.
Quantity
105 systems
Distribution
U.S.: CT, GA, MA, NY, OH, WA, and WV. O.U.S.: N/A
Recall date
November 6, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls