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U.S. Department of Health and Human Services

Class 2 Device Recall Herc Flex Universal Stabilizer Arms

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  Class 2 Device Recall Herc Flex Universal Stabilizer Arms see related information
Date Initiated by Firm March 02, 2021
Create Date April 06, 2021
Recall Status1 Terminated 3 on November 05, 2021
Recall Number Z-1367-2021
Recall Event ID 87504
Product Classification Stabilizer, heart - Product Code MWS
Product Consist of a distal connection mechanism (either standard Terumo Ball Quick Connect or Terumo Shaft Quick Connect), an articulating arm with links, a handle for providing cable tension, and a mechanism to mount the device to a sternal retractor.
Code Information GTIN Code: (01)00699753450950 Catalog Number: T401163 Serial Numbers: T00393, T00394, T00395, T00399, T00403, T00405, T00406, T00407, T00408, T00410, T00411, T00412. 
Recalling Firm/
Manufacturer		 Terumo Cardiovascular Systems Corporation
125 Blue Ball Rd
Elkton MD 21921-5315
For Additional Information Contact Mary Swift
734-741-6056
Manufacturer Reason
for Recall		 There is a potential for the stainless steel locking plates on the device's sternal retractor locking mechanism to fracture.
FDA Determined
Cause 2		 Employee error
Action A customer notification letter will be issued on 03/15/2021 by 2-day FedEx mailing to all (8 total) end users who have received affected product. Terumo CVS will provide a replacement device concurrent with the mailing. Customers will be advised to remove the affected product from use and to return product to Terumo CVS using the instructions provided in the customer letter.
Quantity in Commerce 12
Distribution US Nationwide distribution in the states of NH, WI, NJ, PA, NV, MD, TN, PA.
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.
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