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U.S. Department of Health and Human Services

Class 2 Device Recall Left Heart Kit

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 Class 2 Device Recall Left Heart Kitsee related information
Date Initiated by FirmMarch 31, 2021
Date PostedApril 21, 2021
Recall Status1 Terminated 3 on March 20, 2023
Recall NumberZ-1472-2021
Recall Event ID 87647
Product Classification System/device, pharmacy compounding - Product Code NEP
ProductLeft Heart Kit, Model Number M20268. for blood pressure monitoring.
Code Information Lot Numbers: 4002486, 4019146, 4036647
FEI Number 3012307300
Recalling Firm/
Manufacturer		 Smiths Medical ASD Inc.
6000 Nathan Ln N
Minneapolis MN 55442-1690
For Additional Information ContactDave Halverson
763-383-3072
Manufacturer Reason
for Recall		Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or incomplete welds. These are components for various cardiac kits including pressure monitoring devices and interventional imaging devices.
FDA Determined
Cause 2		Process control
ActionThe firm initiated the action by email on 03/31/2021. The Recall Notice instructs consignees to identify, and quarantine affected product in their possession. A list of affected product has been included on the Recall Notice for consignees to identify affected product. The consignees have been instructed to complete the response form, and return it to fieldactions@smiths-medical.com within 10 days of receipt. After the completed Recall Response Form has been submitted to fieldactions@smiths-medical.com, the consignee will be contacted to arrange return of any affected product in their possession. Distributors have been instructed that if they have distributed potentially affected product to their customers to immediately notify them of the Recall.
Quantity in Commerce600 devices
DistributionDistribution US nationwide including Puerto Rico, Austria, Canada, Chile, Ecuador, Hong Kong, Mexico, Slovenia, Brazil, South Africa, Colombia, and 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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