Mindray DS USA, Inc. dba Mindray North America
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Potential for anesthesia leakage.
Sevoflurane (SEVO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following: 1. Sev E_Vap. (Safety Filling adapter), Part Number: 115-066756-00. 2. Exchange Sev E_Vap. (Safety Filling adapter), Part Number: E115-066756-00. Product Description: The Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The A9 Anesthesia System utilizes V90 electronic vaporizers for anesthetic agent delivery.
1. Part Number: 115-066756-00; DI: 06936415975777; Serial Numbers: AH6A45000871, AH6A45000880, AH6A45000881, AH6A46000929, AH6A46000931, AH6A46000944, AH6A47001200, AH6A44000657, AH6A44000658, AH6A44000661, AH6A44000664, AH6A44000677, AH6A44000678, AH6A44000680, AH6A44000768, AH6A44000778, AH6A46000925, AH6A46000927, AH6A46000928, AH6A46000935, AH6A46000937, AH6A46001114, AH6A47001159, AH6A47001164, AH6A47001174, AH6A47001201, AH6A45000872, AH6A46000932, AH6A46000939, AH6A46000940, AH6A47001196, AH6A47001202, AH6A47001207, AH6A47001215, AH6A46001102, AH6A46001111, AH6A46001116, AH6A47001160, AH6A47001161, AH6A47001163, AH6A47001165, AH6A47001166, AH6A47001167, AH6A47001178, AH6A46001097, AH6A46001117, AH6A44000645, AH6A44000647, AH6A44000648, AH6A44000651, AH6A44000655, AH6A44000656, AH6A44000659, AH6A44000660, AH6A44000662, AH6A44000684, AH6A44000686, AH6A44000687, AH6A44000688, AH6A44000690, AH6A44000691, AH6A44000695, AH6A44000696, AH6A44000698, AH6A44000700, AH6A44000702, AH6A44000703, AH6A44000770, AH6A44000776, AH6A46001090, AH6A46001109, AH6A46001118, AH6A47001171, AH6A47001176, AH6A44000771, AH6A44000772, AH6A45000815, AH6A45000819, AH6A45000821, AH6A45000822, AH6A45000824, AH6A45000825, AH6A45000829, AH6A45000832, AH6A45000834, AH6A45000835, AH6A45000868, AH6A45000869, AH6A45000870, AH6A45000873, AH6A45000874, AH6A45000875, AH6A45000876, AH6A45000877, AH6A45000878, AH6A45000882, AH6A45000883, AH6A45000884, AH6A46000926, AH6A46000930, AH6A46000936, AH6A46000943, AH6A44000779, AH6A44000674, AH6A44000692, AH6A44000777, AH6A45000879, AH6A47001170, AH6A44000765, AH6A44000769, AH6A47001175, AH6A28000535, AH6A46000918, AH6A46000923, AH6A46000924, AH6A46000934, AH6A46000938, AH6A46001091, AH6A46001093, AH6A46001099, AH6A46001100, AH6A46001101, AH6A46001103, AH6A46001104, AH6A46001107, AH6A46001108, AH6A46001110, AH6A46001113, AH6A47001177, AH6A44000679, AH6A44000683, AH6A44000689, AH6A44000697, AH6A44000649, AH6A44000650, AH6A44000652, AH6A44000676, AH6A44000681, AH6A44000682, AH6A44000699, AH6A44000704, AH6A44000766, AH6A44000773, AH6A44000775, AH6A44000780, AH6A47001216, AH6A44000693. 2. Part Number: E115-066756-00; DI: 06936415975777; Serial Number: AH6A45000885.
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →