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U.S. Department of Health and Human Services

Class 2 Device Recall Reprocessed LASSO NAV eco Electrophysiology Catheter

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 Class 2 Device Recall Reprocessed LASSO NAV eco Electrophysiology Cathetersee related information
Date Initiated by FirmAugust 23, 2018
Create DateNovember 14, 2018
Recall Status1 Terminated 3 on February 04, 2021
Recall NumberZ-0467-2019
Recall Event ID 81321
510(K)NumberK112292 
Product Classification Catheter, recording, electrode, reprocessed - Product Code NLH
ProductStryker Sustainability Solutions LASSO NAV eco Reprocessed Diagnostic EP Catheters designed to obtain electrophysiological mapping of the cardiac structures of the heart.
Code Information Item Number Serial Number D134903 2519054 D134903 2534027  Note: Item # D134909 is not approved for reprocessing by Stryker s Sustainability Solutions Division. Therefore, SSS does not create or possess D134909 labeling. SSS did not receive labeling from the manufacturer.
FEI Number 3009350690
Recalling Firm/
Manufacturer		 Stryker Sustainability Solutions
1810 W Drake Dr
Tempe AZ 85283-4327
Manufacturer Reason
for Recall		Electrophysiology catheters were identified to be item # D134903 and distributed. It was subsequently determined that these catheters are item # D134909, which is not approved for reprocessing.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 10/30/2018 an Urgent Medical Device Recall notice was hand-delivered by a sales representative to the customer. The customer was notified that the affected devices had already been returned via the normal collections process. If affected devices were forwarded to additional facilities, the customer was asked to communicate this recall to them and to provide them with the recall effectiveness check form. Customers were asked to complete and return the recall effectiveness check form.
Quantity in Commerce2
DistributionUS: KS OUS: None
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = NLH
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