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U.S. Department of Health and Human Services

Class 2 Device Recall IUD INSERTION KIT 935K

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  Class 2 Device Recall IUD INSERTION KIT 935K see related information
Date Initiated by Firm July 29, 2011
Date Posted August 15, 2011
Recall Status1 Terminated 3 on October 29, 2012
Recall Number Z-3025-2011
Recall Event ID 59661
510(K)Number K073182  
Product Classification Uterine tenaculum. - Product Code HDC
Product GYNDisposables 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 Contact James K. Patterson, MD
888-377-2203
Manufacturer Reason
for Recall		 Lack of sterility assurance.
FDA Determined
Cause 2		 Process design
Action GYN 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 Commerce 3987 units
Distribution Nationwide Distribution.
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 = HDC and Original Applicant = GYN-DISPOSABLES, INC.
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