Class II — Bayer Medical Care, Inc.
| Recalling firm | Bayer Medical Care Inc. |
|---|---|
| Registered facility | View this company's 4 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | If the head mount knob is not properly tightened and the operator directly uses the injector head to move the unit, it may become disengaged, causing the injector head to become loose or fall. |
| Product | MAVIG Portegra or Portegra2 Overhead Counterpoise System (OCS) used in conjunction with the Medrad Stellant CT Injection System (Certegra Workstation), Medrad Mark 7 Arterion" Injection System, or Medrad Mark V ProVis Injection System, Catalog Numbers: Catalog numbers: OCS CEIL (58-S, 58-P, 85-S, 85-P, 100-S, 100-P, 70Si, 97Si), OCS TRACK (58-S, 58-P, 80-S, 80-P), OCS WALL (S, P), OCS (115A, 115CT, 125CT, 125A, 135A, 135CT, 145, 155A, 165A, 115AS, 115CTS), EOC (700, 700S), EOW 700, EOA 700 |
| Quantity | 16656 |
| Distribution | The products were distributed US nationwide. The products were distributed to the following foreign countries: Algeria, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Belgium, Bermuda, Brazil, Brunei Darussalam, Canada, Chile, China, Cote D'Ivoire, Cuba, Curacao, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Faroe Islands, Finland, France, French Guiana, French Polynesia, Germany, Ghana,… |
| Initiated | 2018-12-14 |
| Classified | 2019-01-15 |
| Terminated | 2020-06-16 |
| Recall number | Z-0745-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Bayer Medical Care, Inc. (Z-0745-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/81808/
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