Z-0384-05

Ultrasound Probe Drape Tapered to 1.5' Sterile 8' x 60', Product Number 781-983; Manufactured by Hydo-Med...

Name: Z-0384-05 Ultrasound Probe Drape Tapered to 1.5' Sterile 8' x 60', Product Number 781-983; Manufactured by Hydo-Med...
Creator: Hydro Med Products, Inc
Published: 2000-09-28
License: https://open.fda.gov/license/

Hydro-Med Products, Inc. / initiated 2000-09-28 / Terminated / root cause: packaging

FDA source

Hydro Med Products, Inc began a recall of 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 on 2000-09-28. The reason FDA records is "Defective packaging, potential for breech in sterility". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0384-05
Status: Terminated
Initiated: 2000-09-28
Posted: 2005-01-06
Terminated: 2008-04-01
Recalling firm: Hydro-Med Products, Inc.
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
Product code: MMP Cover, Barrier, Protective
Reason for recall: Defective packaging, potential for breech in sterility.
Root cause tag: packaging
FDA root 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
Product codes and lots: Lot Number A 7611

Product code MMP

K940151Class IIUltrasound Probe DrapeHydro-Med Products, Inc. / cleared 1994-11-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)