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Terminated

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

FDA Recall Z-0384-05 · Posted 2005-01-06

Recalling FirmHydro Med Products, Inc
Recall StatusTerminated
Product CodeMMP
Date Initiated2000-09-28
Date Terminated2008-04-01
Product Quantity35 cases, 10 units per case

Reason for Recall

Defective packaging, potential for breech in sterility.

Firm Action

The firm initiated the recall on 09/28/00 via letter. The firm followed up with phone call contact to 100% of customers.

Root Cause

Other

Distribution Pattern

The product was distributed nationwide to distributors and hospitals in the following states IA, WV, OR, PA, CA, and TN

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K940151ULTRASOUND PROBE DRAPEHydro-Med Products, Inc. · 1994-11-14

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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