| Class 2 Device Recall Richard Wolf Medical Instrument Corporation | |
Date Initiated by Firm | July 09, 2014 |
Date Posted | November 06, 2014 |
Recall Status1 |
Terminated 3 on April 24, 2017 |
Recall Number | Z-0037-2015 |
Recall Event ID |
68777 |
PMA Number | P870080 |
Product Classification |
Device, occlusion, tubal, contraceptive - Product Code KNH
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Product | The Hulka Clip is a sterile packaged medical device that carries a two year expiration date. It is packaged two clips per procedural tray. Theses procedural trays are then sealed in a Tyvek/Mylar pouch and packaged in a cardboard shipping carton with ten pouches in each shipping carton. |
Code Information |
Product Code: 4986.09; Lot: 51000232 |
Recalling Firm/ Manufacturer |
Richard Wolf Medical Instruments Corp. 353 Corporate Woods Pkwy Vernon Hills IL 60061-3110
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For Additional Information Contact | Ms. Lisa Williams 847-913-1113 Ext. 225 |
Manufacturer Reason for Recall | Richard Wolf Medical Instrument Corporation is recalling Hulka Clip Tubal Occluding Device lot 51000232. The devices are being recalled as a part of an investigation into a biocompatibility test discrepancy where the recalled lot (lot 51000232) passed final release testing, but the subsequent lot failed biocompatibility testing on a component that was also used to manufacture lot 51000232. |
FDA Determined Cause 2 | Nonconforming Material/Component |
Action | "Urgent: Medical Device Recall" letters dated July 9, 2014 were sent to all direct accounts (customers). The letters included instructions for customers to: 1) inspect their inventories for the recalled products; 2) contact Richard Wolf Medical Instruments at 800-323-9653 x 225 or 380 to notify Richard Wolf Medical Instruments if you have any devices in inventory; 3) review your records and report the number, if any, of Hulka Clips from lot 51000232 that were implanted in your patients on the Recall Response Form; 4) complete and return the Recall Response Form attached to the letter; and, 5) a RMA number will be provided to customers returning the recalled products and those customers will receive a credit. All returned product should be sent to the attention of Ms. Lisa Williams, Regulatory Specialist. Customers with questions can contact Richard Wolf Medical Instruments at 800-323-9653 x 225 or 380. |
Quantity in Commerce | 73 cartons (1,460 clips) |
Distribution | Worldwide distribution: US (Nationwide) including states of: (AK, AL, CO, CT, FL, GA, IA, IN, KY, LA, MI, MO, MS, NC, NY, OH, OR, PA, SC, TN, TX, VA, WA, WV; and country of: Germany. |
Total Product Life Cycle | TPLC Device Report |
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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.
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PMA Database | PMAs with Product Code = KNH
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