TheraSphere Administration Set, REF OTT-SPE-FP-226 (990226.SPE)
Check against the official notice below — it lists the full affected range.
Boston Scientific Corporation is recalling 4,980 TheraSphere Administration Sets (model REF OTT-SPE-FP-226) distributed worldwide due to a potential for leaks and loosening at the patient catheter connection. The affected product was distributed throughout the United States and to 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. The recalled sets can be identified by GTIN 05060116920253 and lot numbers 001E, 002E, 004E, 005E, 006E, 007E, 114E, 690E, or 692E.
The source document does not specify what actions an affected consumer should take or provide a remedy for this recall.
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: 4980 sets Lot/code info: GTIN 05060116920253, Lot Numbers: 001E, 002E, 004E, 005E, 006E, 007E, 114E, 690E, 692E
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.