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U.S. Department of Health and Human Services

Class 2 Device Recall LIFEPAK 35

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 Class 2 Device Recall LIFEPAK 35see related information
Date Initiated by FirmJanuary 21, 2025
Date PostedFebruary 05, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1102-2025
Recall Event ID 96048
510(K)NumberK240377 
Product Classification Cable, transducer and electrode, patient, (including connector) - Product Code DSA
ProductLIFEPAK 35 ECG cable REF 11111-000041
Code Information Catalog Number: 11111-000041 UDI-DI code: 00883873834596 Lot/Serial Number: 0224
FEI Number 3015876
Recalling Firm/
Manufacturer		 Physio-Control, Inc.
11811 Willows Rd Ne
Redmond WA 98052-2003
For Additional Information ContactJoyce Staggs
425-867-4597
Manufacturer Reason
for Recall		Product shipped with incorrect IFU. IFU does not include proper cleaning/disinfection instructions
FDA Determined
Cause 2		Labeling Change Control
ActionOn 01/21/2025, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Letter to customers informing them that Stryker discovered that an incorrect version of the Instructions for Use (IFU) for the 3-wire extended precordial ECG cable for the LIFEPAK 35 were distributed to customers. This version did not include information regarding disinfection of the 3-wire cable. Customer are instructed to: 1. Immediately check internal inventory to locate the product listed on the attached business reply form. 2. Remove and quarantine any affected product from use. 3. To confirm receipt of this Medical Device Correction Notice and understanding of the provided information, email the enclosed Business Reply Form (BRF) by January 31st, 2025 date, to RSRecall@Stryker.com. 4. Upon receipt of the completed business reply form, Stryker will contact customers to arrange for the return and replacement of their product(s). 5. Maintain awareness of this communication internally until all required actions have been completed within their facility. Ensure this letter is kept with the affected device until replacement. 6. 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, contact Customer Service +1 800 442 1142 or by email RSRecall@Stryker.com.
Quantity in Commerce245 units
DistributionU.S. Nationwide distribution in the states of CA, FL, GA, IA, IN, KY, MD, MI, MO, NE, NV, NY, OH, OR, SC, TN, TX, and WI.
Total Product Life CycleTPLC 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.
510(K) Database510(K)s with Product Code = DSA
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