Medical device recalls
39226 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2019-06-05FDA-DeviceMaquet Cardiovascular, LLCClass IIMaquet Getinge-BO-TOP 36504 ADULT ECC PACK Material: 701065765
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
- 2019-06-05FDA-DeviceMaquet Cardiovascular, LLCClass IIMaquet Getinge-BO-T 46200 3/16" x 1/4" Neonate Pack Material: 701065620
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
- 2019-06-05FDA-DeviceMaquet Cardiovascular, LLCClass IIMaquet Getinge-BEQ-TOP 31204 CUSTOM PACK PEDI Material: 701065512
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
- 2019-06-05FDA-DeviceMaquet Cardiovascular, LLCClass IIMaquet Getinge-BEQ-TOP 31203 CUSTOM PACK NEO Material: 701065510
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
- 2019-06-05FDA-DeviceMaquet Cardiovascular, LLCClass IIMaquet Getinge-BEQ-TOP 27609 ECC PACK 1/4" Material: 701065504
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
- 2019-06-05FDA-DeviceMaquet Cardiovascular, LLCClass IIMaquet Getinge-BO-T 41301 BUMC ECC PACK Material: 701065209
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
- 2019-06-05FDA-DeviceMaquet Cardiovascular, LLCClass IIMaquet Getinge-BEQ-TOP 37302 Quadrox iD Pediatric Pack Material: 701065190
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
- 2019-06-05FDA-DeviceMaquet Cardiovascular, LLCClass IIMaquet Getinge-BEQ-TOP 5909 1/4 PACK W QPID Material: 701064992
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
- 2019-06-05FDA-DeviceMaquet Cardiovascular, LLCClass IIMaquet Getinge-BEQ-T 8069 Pediatric Pack Material: 701064965
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
- 2019-06-05FDA-DeviceMaquet Cardiovascular, LLCClass IIMaquet Getinge-BEQ-TOP 41201 ECC 3/8 PUMP PAC Material: 701064867
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
- 2019-06-05FDA-DeviceMaquet Cardiovascular, LLCClass IIMaquet Getinge-BO-T 44201 MAYO PULMONARY PACK Material: 701064834
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
- 2019-06-05FDA-DeviceMaquet Cardiovascular, LLCClass IIMaquet Getinge-BEQ-T 44200 MAYO PULMONARY P Material: 701064831
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
- 2019-06-05FDA-DeviceMaquet Cardiovascular, LLCClass IIMaquet Getinge-BEQ-TOP 44701 PEDIATRIC ECC Material: 701064825
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
- 2019-06-05FDA-DeviceMaquet Cardiovascular, LLCClass IIMaquet Getinge-BEQ-T 27904 3/8 TRANSPORT PACK Material:701064804
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
- 2019-06-05FDA-DeviceMaquet Cardiovascular, LLCClass IIMaquet Getinge-BEQ-TOP 24105 ECC PACK Material:701064757
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
- 2019-06-05FDA-DeviceMaquet Cardiovascular, LLCClass IIMaquet Getinge-BEQ-T 30601 CMC ACCESSORY KIT Material: 701064701
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
- 2019-06-05FDA-DeviceMaquet Cardiovascular, LLCClass IIMaquet Getinge-BEQ-T 5908 TCH HLS ANCILLARY Material: 701064590
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
- 2019-06-05FDA-DeviceMaquet Cardiovascular, LLCClass IIMaquet Getinge-BEQ-T 5211 LARGE ECC SET Material:701064560
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
- 2019-06-05FDA-DeviceMaquet Cardiovascular, LLCClass IIMaquet Getinge-BEQ-TOP 21506 ECC PACK Material:701064505
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
- 2019-06-05FDA-DeviceMaquet Cardiovascular, LLCClass IIMaquet Getinge-BEQ-TOP 25003 3/8X3/8 TO 7LPM Material: 701063255
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
- 2019-06-05FDA-DeviceMaquet Cardiovascular, LLCClass IIMaquet Getinge-BEQ-TOP 41200 ECC 1/4 PUMP PAC Material: 701063149
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
- 2019-06-05FDA-DeviceMaquet Cardiovascular, LLCClass IIMaquet Getinge-BEQ-TOP 30901 CUSTOM CPB PACK Material:701063071
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
- 2019-06-05FDA-DeviceMaquet Cardiovascular, LLCClass IIMaquet Getinge-BEQ-TOP 40700 HUNTINGTON Material:701062899
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
- 2019-06-05FDA-DeviceMaquet Cardiovascular, LLCClass IIMaquet Getinge-BEQ-TOP 2202 NEONATAL SPECIALT Material:701062613
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
- 2019-06-05FDA-DeviceMaquet Cardiovascular, LLCClass IIMaquet Getinge-BEQ-T 39700 ECC PACK Material:701062473
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
- 2019-06-05FDA-DeviceMaquet Cardiovascular, LLCClass IIMaquet Getinge-BEQ-TOP 26402 ECC PACK Material: 701062310
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
- 2019-06-05FDA-DeviceMaquet Cardiovascular, LLCClass IIMaquet Getinge-BEQ-TOP 38900 ECC PACK Material: 701056368
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
- 2019-06-05FDA-DeviceMaquet Cardiovascular, LLCClass IIMaquet Getinge-BEQ-T 4906 PEDIARIC CPB PACK Material: 701056041
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
- 2019-06-05FDA-DeviceMaquet Cardiovascular, LLCClass IIMaquet Getinge-T 8029 PRESSURE PIGTAIL 6" Material: 701055995
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
- 2019-06-05FDA-DeviceMaquet Cardiovascular, LLCClass IIMaquet Getinge-T 8028 PRESSURE PIGTAIL 4" Material: 701055993
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
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