Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Sustainability Reprocessed Lasso 2515 NAV eco Variable Diagnostic EP Catheter

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Stryker Sustainability Reprocessed Lasso 2515 NAV eco Variable Diagnostic EP Cathetersee related information
Date Initiated by FirmMay 10, 2024
Date PostedJuly 03, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2268-2024
Recall Event ID 94726
510(K)NumberK112292 
Product Classification Catheter, recording, electrode, reprocessed - Product Code NLH
ProductStryker Sustainability Solutions, BW Lasso 2515 NAV eco Variable Diagnostic EP Catheter, REF: D134301, ELECTRODES: 22, spacing:2-6-2MM, Length 115 cm, STERILE.EO, Rx Only
Code Information (UDI):00885825011680/Serial #: 4175411, 4202651, 4116975, 4202652, 4175410, 4175402
FEI Number 3002615969
Recalling Firm/
Manufacturer		 Stryker Sustainability Solutions
10232 S 51st St
Phoenix AZ 85044-5205
For Additional Information ContactAshley Cupples (Lower)
707-530-1457
Manufacturer Reason
for Recall		Diagnostic electrophysiology (EP) catheters do not meet testing requirements.
FDA Determined
Cause 2		Process control
ActionOn June 11, 2024, Stryker Sustainability Solutions issued a Medical Device Recall notification to affected consignees. Stryker ask consignees to take the following action: 1. Please complete the Urgent Medical Device Recall Business Reply Form Attachment A (page 3) as an acknowledgement of this notification. Please return this completed form through one of the following methods: "Email: SSSPFA@stryker.com or To your Stryker s Sustainability Solutions Sales Representative or via: Fax: 480-763-5345 5. 2.Maintain awareness of this communication internally. Response is required.
Quantity in Commerce 6 units
DistributionInternational distribution to the country of Japan.
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 = NLH
-
-