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U.S. Department of Health and Human Services

Class 2 Device Recall TUOHY Epidural Needle

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 Class 2 Device Recall TUOHY Epidural Needlesee related information
Date Initiated by FirmJuly 24, 2017
Create DateNovember 09, 2017
Recall Status1 Terminated 3 on July 06, 2023
Recall NumberZ-0089-2018
Recall Event ID 77842
510(K)NumberK030562 
Product Classification Epidural anesthesia kit - Product Code OGE
ProductTUOHY Epidural Needle, 20g x 3.5in(8.9cm) TW, 10 units, Calibrated, Plastic Hub, Fixed Wing, Sterile, Rx only
Code Information Lot No. 12358202; Ref No. 125-2035T.
FEI Number 1643059
Recalling Firm/
Manufacturer		 Epimed International
13958 Diplomat Dr
Farmers Branch TX 75234-8805
For Additional Information ContactBobbi Harrington
518-848-3914
Manufacturer Reason
for Recall		Potential for partially incomplete seal of product, impacting sterility.
FDA Determined
Cause 2		Employee error
ActionConsignees were contacted 07/24/2017 via email and phone, notifying them of the recall. Consignees were asked to contact the recalling firm to report the number of affected product on hand. A second, updated recall notification was sent on 08/04/2017. Instructions included to examine inventory and quarantine any affected product, contact Epimed to arrange return/credit of the affected product, and complete and return the response form.
Quantity in Commerce263 units
DistributionDomestic: AR, CA, IA, IN, KY, LA, MI, NY, OH, OR, TN, TX, & WA. Foreign: Canada, Czech Republic, Germany ,& Turkey.
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 = OGE
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