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U.S. Department of Health and Human Services

Class 2 Device Recall Kendall

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 Class 2 Device Recall Kendallsee related information
Date Initiated by FirmOctober 08, 2004
Date PostedNovember 02, 2004
Recall Status1 Terminated 3 on May 15, 2012
Recall NumberZ-0148-05
Recall Event ID 30196
510(K)NumberK012736 
Product Classification Needle, Hypodermic, Single Lumen - Product Code FMI
ProductMonoject 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 ContactJames Welsh
508-261-8532
Manufacturer Reason
for Recall
Needle cannula may separate from the hub during use
FDA Determined
Cause 2
Other
ActionRecall letters requesting product return were mailed to all customers on October 8, 2004
DistributionNationwide
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 = FMI
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