FDA Medical Device Recalls (openFDA)
Medrad Inc: MEDRAD Sterile Disposable Syringe Kit, catalog number DSK 130-Q, Angiographic Syringe for delivery of contrast media.
- Recall number
- Z-1228-2009
- Recalling firm
- Medrad Inc
- Product
- MEDRAD Sterile Disposable Syringe Kit, catalog number DSK 130-Q, Angiographic Syringe for delivery of contrast media.
- Status
- Terminated
- Initiated
- 2009-01-29
- Posted
- 2009-06-01
- Terminated
- 2009-06-04
- Reason
- Possible compromised sterility due to holes in styrene tray
- Root cause
- Packaging process control
- Action
- On 1/29/09, Medrad issued an Urgent Medical Device Recall letter. Customers were requested to check their inventory for any of the affected batch. If the customer has affected product, they are instructed to contact the firm to make arrangement for the return of the product. Non responders were sent additional notifications via FedEx on 3/2/09 and 4/1/09.
- Quantity
- 2958 kits
- Distribution
- Nationwide: AL, AZ, CA, FL, IL, LA, MA, MT, NC, NY, OH, TX, and WI.
- Lot, serial or model codes
- catalog number DSK 130-Q. Lot number 72372
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DXT
- Firm FEI
- 2520313
- Firm city
- Indianola
- Firm state
- PA
- 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