PET Infusion Pump
FDA device recall Z-0400-2017 · posted 2016-11-11 · Terminated
Recall details
- Recalling firm
- Bayer Healthcare
- Reason for recall
- The Source Administration Sets (SAS) used with the Medrad Intego PET Infusion System do not meet pressure testing specifications in an occlusion situation when the product is more than one year past manufacturing date.
- Action taken
- Bayer mailed an Urgent Medical Device Customer Notification letter to the affected consignees on September 30, 2016 asking that they review their current SAS inventory and determine if you have any product that is more than one year past its manufacturing date, Quarantine unused units and call Bayer Customer Care line to receive a Return Goods Authorization (RGA) number for the product's return.
- Root cause
- Process control
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 165,127 (79,714 units in U.S.)
- Distribution
- Distributed Nationwide and internationally to : Taiwan, Ukraine, Turkey, Thailand, Slovania, Singapore, Sweden, Saudi Arabia, Serbia, Romania, Qatar, Portugal, Poland, Panama, Oman, Norway, The Nether
- Date initiated
- 2016-09-30
- Date posted
- 2016-11-11
- Date terminated
- 2017-03-24
- Location
- Indianola, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MEDRAD INTEGO PET INFUSION SYSTEM, SOURCE ADMINISTRATION SET, PATIENT ADMINSTRATIN SET MODEL INT SYS 100, INT CSS, INT C (K100798) | Medrad, Inc. | 2010-06-23 |
| MEDRAD INTEGO PET INFUSION SYSTEM (K080297) | Medrad, Inc. | 2008-06-17 |