Class 2 Device Recall Spectrum

• Date Initiated by Firm: September 28, 2000
• Date Posted: January 06, 2005
• Recall Status: Terminated on April 01, 2008
• Recall Number: Z-0384-05
• Recall Event ID: 30656
• 510(K)Number: K940151
• Product Classification: Cover, Barrier, Protective - Product Code MMP
• Product: Ultrasound Probe Drape Tapered to 1.5' Sterile 8' x 60', Product Number 781-983; Manufactured by Hydo-Med Products Inc., 2930 Ladybird Ln., Dallas, TX 75220
• Code Information: Lot Number A 7611
• Recalling Firm/ Manufacturer: Hydro Med Products, Inc; 2930 Ladybird Ln; Dallas TX 75220-1417
• Manufacturer Reason for Recall: Defective packaging, potential for breech in sterility.
• FDA Determined Cause: Other
• Action: The firm initiated the recall on 09/28/00 via letter. The firm followed up with phone call contact to 100% of customers.
• Quantity in Commerce: 35 cases, 10 units per case
• Distribution: The product was distributed nationwide to distributors and hospitals in the following states IA, WV, OR, PA, CA, and TN
• 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 = MMP