TheraSphere Administration Set, REF OTT-SPE-FP-001 (990264.SPE)
Check against the official notice below — it lists the full affected range.
Boston Scientific Corporation is recalling 4,200 TheraSphere Administration Sets (model REF OTT-SPE-FP-001, GTIN 05060116920635) due to a potential for leaks and loosening at the patient catheter connection. The affected sets were distributed worldwide, including throughout the United States and in Belgium, Canada, Germany, Spain, France, the United Kingdom, Hong Kong, Ireland, Israel, India, Italy, the Netherlands, Poland, Portugal, Saudi Arabia, Singapore, Switzerland, Turkey, and Argentina. The recall involves six specific lot numbers: 61673698, 61673699, 61673700, 61673702, 61694124, 61705932, 61705933, 61706656, and 61732176.
The recall record does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Potential for leaks and loosening at the patient catheter connection
Reason for recall: Potential for leaks and loosening at the patient catheter connection Distribution: Worldwide distribution - US Nationwide and the countries of Belgium, Canada, Germany, Spain, France, United Kingdom/Great Britain, Hong Kong, Ireland, Israel, India, Italy, Netherlands, Poland, Portugal, Saudi Arabia, Singapore, Switzerland, Turkey, and Argentina. Quantity: 4200 sets Lot/code info: GTIN 05060116920635, Lot Numbers: 61673698, 61673699, 61673700, 61673702, 61694124, 61705932, 61706656, 61705933, 61732176
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.