FDA Medical Device Recalls (openFDA)
Hydro Med Products, Inc: 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
- Recall number
- Z-0384-05
- 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
- Status
- Terminated
- Initiated
- 2000-09-28
- Posted
- 2005-01-06
- Terminated
- 2008-04-01
- Reason
- Defective packaging, potential for breech in sterility.
- 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
- 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
- Lot, serial or model codes
- Lot Number A 7611
- 510(k) numbers
- ["K940151"]
- PMA numbers
- not on file
- Product code
- MMP
- Firm FEI
- 1625657
- Firm city
- Dallas
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28