Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall IUD INSERTION KIT 935K

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall IUD INSERTION KIT 935Ksee related information
Date Initiated by FirmJuly 29, 2011
Date PostedAugust 15, 2011
Recall Status1 Terminated 3 on October 29, 2012
Recall NumberZ-3025-2011
Recall Event ID 59661
510(K)NumberK073182 
Product Classification Uterine tenaculum. - Product Code HDC
ProductGYNDisposables Inc, IUD INSERTION KIT 935K, STERILE, SINGLE USE, Tenaculum 356T, Uterine Sound 906S, Scissors, Povidone-Iodine Solution, (3) Swabsticks, Paper Towel, STERILE EO, REF 935K, QTY 1, GYN Disposables,Inc. 2671 Appling Road, Memphis, TN 38133, ph 901.377.2200, fx 901.377.2207 Intended for intrauterine device (IUD) insertion.
Code Information Catalog Number: 935K. Lot number: 61034034.
Recalling Firm/
Manufacturer		 GYN Disposables Inc
3150 Stage Post Dr Ste 103
Memphis TN 38133-4050
For Additional Information ContactJames K. Patterson, MD
888-377-2203
Manufacturer Reason
for Recall		Lack of sterility assurance.
FDA Determined
Cause 2		Process design
ActionGYN Disposables Inc. sent out an "Urgent: Medical Device Recall" letter dated July 29, 2011 to all affected customers The letter includes: product affected, description of problem and asks customers quarantine all affected product. They can contact GYN Disposables to have the product picked up and to receive credit. A Response Form is also included. For questions on this recall call (888) 372-2203, extension 101.
Quantity in Commerce3987 units
DistributionNationwide Distribution.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = HDC
-
-