“We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
Manufacturer Model Number # 2035-112-010
Product Description : Head End Left, 2 Stage I.V. Pole
Manufacturer Model Number # 2035-113-011
Product Description : Head End Right, 2 Stage I.V. Pole
Manufacturer Model Number # 0785-035-101
Product Description : 26", 2 Stage IV Pole Assembly
Manufacturer Model Number # 0785-035-200
Product Description : 26", 3 Stage IV Pole Assembly
Manufacturer Model Number # 0785-035-300
Product Description : 30", 3 Stage IV Pole Assembly
Manufacturer Model Number # 0785-035-401
Product Description : 30", 2 Stage IV Pole Assembly
For I.V. Pole option numbers ship as service kits. ( Please see attachment )