Date Initiated by Firm | October 08, 2004 |
Date Posted | November 02, 2004 |
Recall Status1 |
Terminated 3 on May 15, 2012 |
Recall Number | Z-0148-05 |
Recall Event ID |
30196 |
510(K)Number | K012736 |
Product Classification |
Needle, Hypodermic, Single Lumen - Product Code FMI
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Product | Monoject Bone Marrow Biopsy / Aspiration Tray with ''I'' type 16G x 4 inch needle
Product Number: 8881847019 |
Code Information |
All lots of the following codes with lot numbers in the range of 4086027 through 4275213 (inclusive): |
Recalling Firm/ Manufacturer |
Kendall Healthcare Products Co 15 Hampshire St Mansfield MA 02048-1113
|
For Additional Information Contact | James Welsh 508-261-8532 |
Manufacturer Reason for Recall | Needle cannula may separate from the hub during use |
FDA Determined Cause 2 | Other |
Action | Recall letters requesting product return were mailed to all customers on October 8, 2004
|
Distribution | Nationwide |
Total Product Life Cycle | TPLC Device Report |
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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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510(K) Database | 510(K)s with Product Code = FMI
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