|
Class 2 Device Recall Terumo "Custom" Cardiovascular Procedure Kit |
|
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.
|
|
|
|