| | Class 2 Device Recall LIFEPAK 15 (LP15) |  |
| Date Initiated by Firm | August 30, 2024 |
|---|
| Date Posted | October 25, 2024 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0230-2025 |
|---|
| Recall Event ID |
95373 |
| PMA Number | P160026 |
|---|
| Product Classification |
Automated external defibrillators (non-wearable) - Product Code MKJ
|
| 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 99577-001256
o 99577-001368
o 99577-001955
o 99577-001956
o 99577-001957
o 99577-001958
o 99577-001962
LIFEPAK 15 intended use monitor/defibrillator. |
|---|
| Code Information |
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 |
| FEI Number |
3015876
|
Recalling Firm/
Manufacturer |
Physio-Control, Inc.
11811 Willows Rd Ne
Redmond WA 98052-2003
|
| For Additional Information Contact | Joyce Staggs
425-867-4597 |
|---|
Manufacturer Reason
for Recall | Due to an out of tolerance tool being used on monitor/defibrillator systems. |
|---|
FDA Determined
Cause 2 | Vendor change control |
|---|
| Action | On 09/30/2024, the firm mailed an "URGENT: MEDICAL DEVICE CORRECTION" Letter to customers informing them that Stryker discovered that an out of tolerance service tool was used on affected LP15 devices in which there is a potential for Noninvasive Blood Pressure (NIBP), System or Auxiliary Power Connectors to be loose. There is a possibility that water or dust may accumulate in the ingress and can lead to permanent or intermittent failures.
Customers are instructed to:
1. Immediately check internal inventory to locate the product listed on the attached business reply form.
2. To confirm receipt of this Medical Device Correction Notice and understanding of the provided information, email the enclosed Business Reply Form (BRF) by October 31st, 2024 date, to RSRecall@Stryker.com.
3. Upon receipt of the completed business reply form, Stryker will contact customers to arrange for corrective action on the device.
4. There are no additional actions that users can and should take. Please continue to follow the Operating Instructions and perform the daily checks and user tests. These tests can be found in the chapter Maintaining the Equipment subsection General Maintenance and Testing .
5. In the interim, Stryker recommends that you continue to use your LP15 device.
6. Maintain awareness of this communication internally until all required actions have been completed within your facility. Please ensure this letter is kept with the affected device until the correction has been completed.
7. Inform Stryker if any of the subject devices have been distributed to other organizations by contacting Stryker at:
a. Device Tracking: rsdevicetracking@stryker.com
b. Website: https://www.strykeremergencycare.com/service-support-overview/device-registration/
If you have any questions or concerns, please contact Customer Service +1 800 442 1142 or by email RSRecall@Stryker.com. |
|---|
| Quantity in Commerce | 105 systems |
|---|
| Distribution | U.S.: CT, GA, MA, NY, OH, WA, and WV.
O.U.S.: N/A |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| PMA Database | PMAs with Product Code = MKJ
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