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U.S. Department of Health and Human Services

Class 2 Device Recall JAMSHIDI (TJ) NEEDLE BONE MARROW

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  Class 2 Device Recall JAMSHIDI (TJ) NEEDLE BONE MARROW see related information
Date Initiated by Firm February 23, 2017
Create Date April 18, 2018
Recall Status1 Terminated 3 on July 09, 2019
Recall Number Z-1424-2018
Recall Event ID 76620
510(K)Number K913306  
Product Classification Tray, surgical, needle - Product Code FSH
Product JAMSHIDI (TJ) NEEDLE BONE MARROW [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 4, d.) 8G x 6, e.) 11G x 6]; STERILE;
Code Information Product Code: a.) TJC3513 / LOT 0000848831, 0000851431, 0000854856; Product Code: b.) TJC4008 / LOT 0000841227, 0000846706, 0000848560, 0000849684, 0000853455; c.) TJC4011 / LOT 0000840667, 0000841228, 0000845874, 0000849717, 0000850937, 0000852121; d.) TJC6008 / LOT 0000841216, 0000848569, 0000851432, 0000852122, 0000853458; e.) TJC6011 / LOT 0000841124, 0000848571, 0000853975
Recalling Firm/
Manufacturer		 Carefusion 2200 Inc
75 N Fairway Dr
Vernon Hills IL 60061-1845
For Additional Information Contact Christine Cox, RN
847-362-9439
Manufacturer Reason
for Recall		 The integrity of the sterile packaging is potentially compromised.
FDA Determined
Cause 2		 Package design/selection
Action On 2/23/2017, firm notified customers of recall via mailed letter. The letter included a recall response form. Customers were directed to either return the affected product along with the response form or destroy it and return the response form, indicating the product had been destroyed. All affected product will be destroyed.
Distribution Nationwide, Australia, Brazil, Canada, China, Japan, Kuwait, Malaysia, Mexico, Netherlands, New Zealand, Philippines, Singapore, South Africa, Taiwan, Thailand, United Arab Emirates, Vietnam
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 = FSH and Original Applicant = PROACT, LTD.
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