|
Class 3 Device Recall Prism Healthcare A CooperSurgical Company |
|
Date Initiated by Firm |
August 17, 2004 |
Date Posted |
October 05, 2004 |
Recall Status1 |
Terminated 3 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 2 |
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.
|
|
|
|