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U.S. Department of Health and Human Services

Class 2 Device Recall PushToSet Intermittent Suction Units

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 Class 2 Device Recall PushToSet Intermittent Suction Unitssee related information
Date Initiated by FirmMarch 12, 2018
Create DateJuly 10, 2018
Recall Status1 Terminated 3 on July 16, 2020
Recall NumberZ-2410-2018
Recall Event ID 80294
Product Classification Regulator, vacuum - Product Code KDP
ProductVacuum Regulator, Push-T-Set Intermittent Suction Unit (PTS-ISU) Product Usage: The vacuum regulator is intended to be used in a medical facility as a means to evacuate media (i.e. fluids) from the body.
Code Information UDI 08688250002085; Catalog Numbers 8702-1251-908, 8701-1251-901, 8705-1251-907, 8701-1251-908, 8705-1251-901; Lot Number ISU177359; Device Unit Numbers JGGW24156, JGGW24193, JGGW24157, JGGW24161 ,JGGW24167, JGGW24169, JGGW24175, JGGW24188, JGGW24189, JGGW24198, JGGW24160 
FEI Number 1419185
Recalling Firm/
Manufacturer		 Ohio Medical Corporation
1111 Lakeside Dr
Gurnee IL 60031-2489
For Additional Information ContactBarbara-Ann Conway-Myers
866-549-6446
Manufacturer Reason
for Recall		Final quality control testing was not completed before the devices were distributed..
FDA Determined
Cause 2		Employee error
ActionOhio Medical notified customers via phone call on about 03/12/2018. The notification included identification of the devices distributed to that customer, explanation that due to the need to the missed additional testing they were removing the devices, and providing a replacement until the testing can be completed.
Quantity in Commerce11 units
DistributionUS Nationwide Distribution in the states of NC, IN, TN, LA,, FL MI, IL.
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.
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