Terumo Advanced Perfusion System 1 Roller Pump, 6 Inch, Catalog Number 816571 - Product Usage: is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical proffes
Check against the official notice below — it lists the full affected range.
Terumo Cardiovascular Systems Corporation has recalled 106 Terumo Advanced Perfusion System 1 Roller Pumps (6 inch, Catalog Number 816571) distributed worldwide to the United States, Hong Kong, India, South Korea, and Taiwan. The pumps were assembled with defective pump shafts that may fail at the threaded location where a locknut is installed. When this occurs, an atypical noise develops as the unsecured shaft end contacts the rotating pulley.
If a recalled pump continues to be used after this failure begins, prolonged operation could eventually cause the pump to stop working entirely, preventing it from creating the necessary pump flow due to pulley loosening and drive belt damage. The record does not specify what remedy is available to consumers who have this product.
Written by software from the official notice below. Not reviewed by a lawyer.
These roller pumps were assembled with pump shafts that may fail at the location of the thread where a locknut is installed. The failure is associated with a noise that is atypical of roller pump operation. The noise is caused when an unsecured shaft end contacts the rotating pulley of the roller pump. Prolonged use of a roller pump in this condition could lead to an eventual pump stop, resulting in the inability to create pump flow due to pulley loosening and drive belt damage.
Reason for recall: These roller pumps were assembled with pump shafts that may fail at the location of the thread where a locknut is installed. The failure is associated with a noise that is atypical of roller pump operation. The noise is caused when an unsecured shaft end contacts the rotating pulley of the roller pump. Prolonged use of a roller pump in this condition could lead to an eventual pump stop, resulting in the inability to create pump flow due to pulley loosening and drive belt damage. Distribution: Worldwide distribution - US Nationwide distribution in the states of CT, FL, LA, MA, MI, NY, and TX. Countries of Hong Kong, India, South Korea, and Taiwan. Quantity: 106 Lot/code info: UDI: 00886799000533; Serial Numbers: 7919 8165 8166 8167 8168 8169 8170 8173 8174 8175 8176 8179 8180 8181 8182 8183 8184 8185 8186 8187 8188 8189 8190 8191 8192 8193 8194 8195 8196 8197 8198 8199 8200 8201 8202 8203 8204 8205 8206 8207 8208 8209 8210 8211 8212 8213 8214 8215 8216 8217 8218 8219 8220 8221 8222 8223 8224 8225 8226 8227 8228 8229 8230 8231 8232 8233 8234 8235 8236 8237 8241 8242 8243 8244 8251 8253 8254 8255 8256 8257 8258 8259 8260 8261 8262 8263 8264 8265 8266 8267 8268 8269 8270 8271 8273 8274 8275 8276 8280 8307 8308 8309 8310 8311 8313 8335
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.