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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 Kitsee related information
Date Initiated by FirmJanuary 29, 2008
Date PostedMarch 28, 2008
Recall Status1 Terminated 3 on July 07, 2009
Recall NumberZ-1310-2008
Recall Event ID 46869
510(K)NumberK982891 
Product Classification Cardiovascular Procedure Kit - Product Code OEZ
ProductCardiovascular 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.
FEI Number 1828100
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
ActionConsignees 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 Commerce739
DistributionNationwide-USA including states of Missouri, Tennessee and Wisconsin-Custom Kits for 3 hospitals.
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 = OEZ
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