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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 Setsee related information
Date Initiated by FirmMay 28, 2019
Date PostedJuly 23, 2019
Recall Status1 Terminated 3 on June 22, 2020
Recall NumberZ-2055-2019
Recall Event ID 82997
510(K)NumberK140792 K153193 
Product Classification Pump, infusion - Product Code FRN
ProductNimbus 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 ContactPeter Nikki
508-315-8201 Ext. 291
Manufacturer Reason
for Recall		Potential for tube leakage
FDA Determined
Cause 2		Employee error
ActionOn 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 Commerce10,800 units
DistributionUS distribution in the state of MA
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 = FRN
510(K)s with Product Code = FRN
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