Recall Z-0745-2019
Bayer Medical Care, Inc. · initiated December 14, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: 3016423 3016423 3016423 59888475 59888475 3016426 3016426 3016426 750001967-2 750001967-2 750001967-2 750001967-9 3016424 3016424 3016423 3016423 3016423 3016423 3016423 3016423 3016423 3016426 3016426 3016426 3016426 3016426 3016426 3016426 3016426 3016426 3016424 3016426 3016426 3016427 3016426 3016426 3016426 3016424 3016424 3016423 3016424 3016426 3016423 3016423 3016423 3016423 3016423 3016423 3016424 3016424 3016427 3016423 3016423 3016426 3016426 3016426 3016426 3016423 3016423 3016423 3016423 3016423 3016426 3016426 3016426 3016426 3016424 3016423 3016423 3016424 3016424 3016426 3016426 3016426 3016426 3016423 3016423 3016424 3016423 3016424 3016426 3016423 3016425 3016426 3016426 3016426 3016426 3016426 3016426 3016426 3016426 3016426 3016426 3016426 3016426 3016423 3016426 3016426 3016426 3016426 3016426 3016426 3016424 3016424 3016424 3016424 3016426 3016426 3016426 3016426 3016426 3016426 3016424 3016424 3016423 3016423 3016426 3016426 3016426 3016424 3016424 3016426 3016426 3016426 3016426 3016426 3016426 3016426 3016426 3016423 3016423 3016423 3016423 3016426 3016426 3016426 3016426 3016424 3016424 3016424 3016424 3016424 3016424 3016424 3016424 3016424 3016424…
Reason for recall
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.
FDA-determined cause: Device Design
Action taken
Urgent Medical Device Field Corrective Action notification letters were sent to customers on 12/12/18.
Details
- Recall number
- Z-0745-2019
- Initiated
- December 14, 2018
- Terminated
- June 16, 2020
- Product code
- DXT – Injector And Syringe, Angiographic
- 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…
- Recalling firm
- Bayer Medical Care, Inc., Indianola, PA