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U.S. Department of Health and Human Services

Class 2 Device Recall McKesson MediPak Vaginal Speculum, 10/bag Reorder No. 118309

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  Class 2 Device Recall McKesson MediPak Vaginal Speculum, 10/bag Reorder No. 118309 see related information
Date Initiated by Firm April 13, 2015
Date Posted June 22, 2015
Recall Status1 Terminated 3 on February 05, 2016
Recall Number Z-1824-2015
Recall Event ID 71313
510(K)Number K841909  
Product Classification Speculum, vaginal, nonmetal - Product Code HIB
Product McKesson Medi-Pak Vaginal Speculum, 10/bag
Reorder No. 11-8309
Used to expose interior of the vagina to facilitate visualization during gynecological and obstetrical procedures
Code Information Work Order:164290
Recalling Firm/
Manufacturer		 CooperSurgical, Inc.
75 Corporate Dr
Trumbull CT 06611-1350
For Additional Information Contact Nana Banafo
203-540-9654
Manufacturer Reason
for Recall		 Small sized specula were incorrectly packaged in printed bags for the medium sized speculum
FDA Determined
Cause 2		 Packaging change control
Action CooperSurgical sent an Urget Medical Device Recall letter dated April 13, 2015, to all affected customers. The letter identified the product, the problem, and the actions to be taken by the customer. Customers were instructed to discontinue use, discard, or return the affected to product to Cooper Surgical. Customers were asked to complete the attached Acknowledgment and Receipt Form for replacement. Customers with questions were instructed to call 203-601-5200.
Quantity in Commerce 9400 units
Distribution Nationwide Distribution including IL, FL, GA, MA, MO, TX, and WA.
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 = HIB and Original Applicant = GALENICA ENTERPRISES, INC.
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