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U.S. Department of Health and Human Services

Class 2 Device Recall Terumo "Custom" Cardiovascular Procedure Kit

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  Class 2 Device Recall Terumo "Custom" Cardiovascular Procedure Kit see related information
Date Initiated by Firm January 29, 2008
Date Posted March 28, 2008
Recall Status1 Terminated 3 on July 07, 2009
Recall Number Z-1310-2008
Recall Event ID 46869
510(K)Number K982891  
Product Classification Cardiovascular Procedure Kit - Product Code OEZ
Product Cardiovascular Procedure Kit, P/N: 70932-01, HCSG-St. Mary's Hospital, Richmond, VA , X-coated Pump and Table Pack, Terumo Cardiovascular, Ashland, MA (the X-coated pump and table pack contains a weighted flexible sucker, Catalog No.: 804113)
Code Information Lot Numbers: GC06, GC27, GD27, GG19, GK07, GL05, GM02, GM30, HA02, HC05, HD12, HE23, HF29, HH23, HK27, HM22, HP03 and KA14.
Recalling Firm/
Manufacturer		 Terumo Cardiovascular Systems Corp
6200 Jackson Rd
Ann Arbor MI 48103-9586
For Additional Information Contact
800-521-2818
Manufacturer Reason
for Recall		 Loose Flash at tip of Weighted Flexible Sucker: A loose strand of stainless steel left on the device during manufacturing by an outside supplier may result in an unretrieved metal fragment remaining in the patient.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Consignees were notified via recall letter, Urgent Medical Device Removal, dated 1/29/08 via fax or email to cease using the weighted sucker in the packs and to use an alternative sucker until replacement product arrives from Terumo.
Quantity in Commerce 739
Distribution Nationwide-USA including states of Missouri, Tennessee and Wisconsin-Custom Kits for 3 hospitals.
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 = OEZ and Original Applicant = CALIFORNIA MEDICAL LABORATORIES, INC.
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