Recall Z-0400-2017— Bayer Healthcare
Class II · Terminated
Class II FDA medical device recall by Bayer Healthcare, initiated 2016-09-30, terminated 2017-03-24. It names 2 FDA 510(k) clearances: K100798, K080297. Product: PET Infusion Pump. Reason: 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..
- Recalling firm
- Bayer Healthcare
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-09-30
- Terminated
- 2017-03-24
- Firm location
- Indianola, PA, United States
510(k) clearances named in this recall
2 on FDA's record- K100798 — MEDRAD INTEGO PET INFUSION SYSTEM, SOURCE ADMINISTRATION SET, PATIENT ADMINSTRATIN SET MODEL INT SYS 100, INT CSS, INT C
- K080297 — MEDRAD INTEGO PET INFUSION SYSTEM
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
PET Infusion Pump
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.