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U.S. Department of Health and Human Services

Class 2 Device Recall CooperSurgical

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  Class 2 Device Recall CooperSurgical see related information
Date Initiated by Firm January 26, 2015
Date Posted March 19, 2015
Recall Status1 Terminated 3 on June 14, 2016
Recall Number Z-1298-2015
Recall Event ID 70286
510(K)Number K912715  
Product Classification Pack, hot or cold, disposable - Product Code IMD
Product CooperSurgical Infant Heel Gel Warmers, P/N 20418
CooperSurgical The Infant Heal Warmer, P/N 2440
To provide gentle heat to increase blood flow and enhance
infant blood sample collection
Code Information Products without an expiration date and lot number
Recalling Firm/
Manufacturer		 CooperSurgical, Inc.
75 Corporate Dr
Trumbull CT 06611-1350
For Additional Information Contact Customer Service
203-601-9818
Manufacturer Reason
for Recall		 Products without expiration date have the remote potential for minor burn
FDA Determined
Cause 2		 Package design/selection
Action CooperSurgical issued Recall Notification letter on January 26, 2015, via Fedex confirmed receipt delivery, to all affected customers. Customers were requested to review inventory and return/destroy product that does not have a expiration and lot number. A fax back form to be returned. Customers with questions should call 203.601.5200. CooperSurgical's expense, arrangements were made to replace any of the affected products that customers had on hand. CooperSurgical provided further instruction on the disposition of the product at the time of replacement.
Quantity in Commerce 20398889 units
Distribution Worldwide Distribution - USA (nationwide) and Internationally to AUSTRALIA, BAHRAIN, BERMUDA, CANADA, FRANCE, LATVIA, LIBYA, MEXICO, NEW ZEALAND, QATAR, SAUDI ARABIA, SINGAPORE, and UNITED KINGDOM.
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 = IMD and Original Applicant = PRISM TECHNOLOGIES, INC.
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