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U.S. Department of Health and Human Services

Class 2 Device Recall Terumo Cardiovascular Systems Kit XCoated Pump and Table Pack

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 Class 2 Device Recall Terumo Cardiovascular Systems Kit XCoated Pump and Table Packsee related information
Date Initiated by FirmMarch 28, 2014
Date PostedApril 16, 2014
Recall Status1 Terminated 3 on December 12, 2014
Recall NumberZ-1465-2014
Recall Event ID 67925
Product Classification Cardiovascular procedure kit - Product Code OEZ
ProductTerumo Cardiovascular Procedure Kit- X-Coated Pump and Table Pack with FX25RE Catalog Number: 73431
Code Information Lot Number: RA-27
Recalling Firm/
Manufacturer		 Terumo Cardiovascular Systems Corp
28 Howe St
Ashland MA 01721-1305
For Additional Information ContactSAME
800-262-3304
Manufacturer Reason
for Recall		Incorrect customer notification label applied to the Tyvek lid of this specific lot of Terumo Cardiovascular Procedure Kits
FDA Determined
Cause 2		Labeling mix-ups
ActionTerumo CVS contacted the affected user on 3/28/14 by phone via phone script to discontinue use and return all affected units in inventory. Terumo CVS will replace or issue credit for returned product.
Quantity in Commerce37 units
DistributionCA
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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