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U.S. Department of Health and Human Services

Class 2 Device Recall Nimbus Administration Set

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  Class 2 Device Recall Nimbus Administration Set see related information
Date Initiated by Firm May 28, 2019
Date Posted July 23, 2019
Recall Status1 Terminated 3 on June 22, 2020
Recall Number Z-2055-2019
Recall Event ID 82997
510(K)Number K140792  K153193  
Product Classification Pump, infusion - Product Code FRN
Product Nimbus Administration Set, REF HS-004, UDI # 00817170020031

Product Usage:
Administer fluids/medication from a container to a patient through a needle or a catheter.
Code Information 1) Lot # 1805002, Exp Date 06/10/2021, 2) Lot # 1712005, Exp Date 12/19/2020, 3) Lot # 1710012, Exp Date 10/22/2020, 4) Lot # 1901003, Exp Date 01/07/2022
Recalling Firm/
Manufacturer		 InfuTronix LLC
177 Pine St
Natick MA 01760-1331
For Additional Information Contact Peter Nikki
508-315-8201 Ext. 291
Manufacturer Reason
for Recall		 Potential for tube leakage
FDA Determined
Cause 2		 Employee error
Action On May 28, 2019 InfuTronix LLC issued Voluntary Recall notices to their customer via email. On June 10, 2019, InfuTronix LLC issued a second notice to customers via email dated June 4, 2019 which provides more information on the reason for recall. On August 6th, 2019, InfuTronix LLC issued a third Urgent Medical Device Recall notice to customers advising them of an additional lot. Customers are advised to take the following actions: 1) Inspect stock and remove all products listd on the notice. 2) Immediately return them to InfuTronix LLC for replacement. 3) Customers may call the telephone number listed or email for instructions on what to do with the product. 4) Please contact InfuTronix at 508-907-7791 Monday to Friday 9:30 am to 5 pm, EST. 5) Return the completed response form via email to Peter.Nikki@infutronix.com.
Quantity in Commerce 10,800 units
Distribution US distribution in the state of MA
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = WRIGHT MEDICAL TECHNOLOGY, INC.
510(K)s with Product Code = FRN and Original Applicant = ZYNO MEDICAL LLC
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