PET Infusion Pump — Class II medical device recall Z-0400-2017
Terminated recall by Bayer Healthcare, reported 2016-11-23, distributed nationwide. The Source Administration Sets (SAS) used with the Medrad Intego PET Infusion System do not meet pressure test
| Recall number | Z-0400-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bayer Healthcare, Indianola, PA, United States |
| Recall initiated | 2016-09-30 |
| Classified | 2016-11-11 |
| Reported by FDA | 2016-11-23 |
| Terminated | 2017-03-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, CH, CL, CZ, DE, DK, ES, FI, FR, GB, IL, IT, KW, LB, LT, MT, MX, NL, NO, OM, PA, PL, PT, QA, RO, RS, SA, SE, SG, TH, TR, TW, UA |
| Reason classes | device malfunction |
| Lot numbers | 20044, 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 and 156 more |
Product
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.