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U.S. Department of Health and Human Services

Class 2 Device Recall Cooper Surgical Mityvac

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  Class 2 Device Recall Cooper Surgical Mityvac see related information
Date Initiated by Firm January 16, 2008
Date Posted September 17, 2008
Recall Status1 Terminated 3 on May 23, 2012
Recall Number Z-1889-2008
Recall Event ID 46377
510(K)Number K011532  
Product Classification Fetal Vacuum Extractor - Product Code HDB
Product Mystic¿ II M-Style¿ Mushroom Cup Vacuum Assisted Delivery System (Ref: 10057). Product is intended to assist a clinician in the delivery of an infant during childbirth. Indicated for use during vaginal delivery and Cesarean sections.
Code Information 57735, 57760, 57761, 57768, 57908, 57909, 57910,  57911, 57912, 57913, 57918, 57919, 57922, 57924, 57925, 58299, and 60815.  
Recalling Firm/
Manufacturer		 Cooper Surgical, Inc.
95 Corporate Dr
Trumbull CT 06611-1350
For Additional Information Contact
203-601-5200 Ext. 8725
Manufacturer Reason
for Recall		 Vacuum Assisted Delivery System may have a loss of vacuum, or the cup will not release from the baby's head. A loss of vacuum may delay delivery and require the use of forceps and/or c-section for delivery. An inability to remove the cup from the head may delay delivery and/or prevent the user from applying forceps if necessary. This may result in serious injury or death to the baby.
FDA Determined
Cause 2		 Device Design
Action On 1/16/08 Cooper Surgical issued an Urgent Notice of Recall via Fed Ex for USA destinations and via e-mail and facsimile for international destinations, and firm confirmed receipt. The letter requests that accounts return recalled product. The recall was extended to three additional lots, and an Urgent Recall Notice dated 3/18/08 was issued. If you have any questions contact Thomas Williams at (203) 601-4741.
Distribution Class II Recall - Worldwide Distribution --- including USA and Australia, Canada, Hong Kong, Latin America, Israel, and New Zealand.
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 = HDB and Original Applicant = PRISM ENTERPRISES, INC.
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