FDA Device recall Z-0400-2017
PET Infusion Pump
- FDA Device
- Class II
- terminated
- Published 2016-11-23
On 2016-11-23 the FDA classified a Class II recall of PET Infusion Pump by Bayer Healthcare, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0400-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-09-30 |
| Published | 2016-11-23 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Bayer Healthcare |
| Distribution | US |
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.
Identifiers
| code_info | Impacted Batch Numbers: 20044 8401230 20110777 20110778 20129053 20130260 20143029 20168043 20168044 20218499…Impacted Batch Numbers: 20044 8401230 20110777 20110778 20129053 20130260 20143029 20168043 20168044 20218499 20223554 20226461 20229069 50378230 50508655 50514420 50515055 50515057 50562833 50562834 50562835 50562836 50572481 50574207 50574208 50574209 50585611 50586105 50596605 50597703 50597850 50600435 50601580 50602572 50604785 50606331 50620077 50629437 50632873 50634213 50657181 50663447 50665086 50669881 50677540 50686154 50688724 50693453 50695189 50696540 50696563 50698651 50699741 50699882 50699883 50705397 50705398 50718205 50718756 50720431 50721421 50725617 50725618 50731457 50735273 50738861 50740290 50743615 50747279 50748947 50750243 50752501 50755005 50781643 50782219 50783201 50784811 50786091 50786092 50786096 50789117 50789131 50789132 50792077 50793811 50795111 50798463 50801293 50801294 50804590 50804591 50808994 50812469 50826288 50826491 50826492 50827614 50827615 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0400-2017%22
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