Class 3 Device Recall Prism Healthcare A CooperSurgical Company

• Date Initiated by Firm: August 17, 2004
• Date Posted: October 05, 2004
• Recall Status: Terminated on May 10, 2012
• Recall Number: Z-0005-05
• Recall Event ID: 29970
• 510(K)Number: K011532
• Product Classification: Extractor, Vacuum, Fetal - Product Code HDB
• Product: Mystic M-Style Mushroom Cup Mityvac Vacuum Assisted Delivery System; Product No: 10047
• Code Information: Lot Number: 30115
• Recalling Firm/ Manufacturer: CooperSurgical, Inc.; 95 Corporate Dr; Trumbull CT 06611-1350
• For Additional Information Contact: Thomas Williams; 203-601-5200
• Manufacturer Reason for Recall: Product is mislabeled as a Mushroom Cap Vacuum but actually contains a Bell Style Assisted Delivery System
• FDA Determined Cause: Other
• Action: CooperSurgical telephoned consignees on 8/18/04 and sales representatives to visit the account for removal of recalled product.
• Quantity in Commerce: 495 units
• Distribution: FL, IA, KS, GA, MA, MN, MS, NE, NY, OH, OK, VA, ME, TX, VA Foreign: Italy
• 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.