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- (1)Material: 701065765R01 BO-TOP 36504 Adult ECC Pack (2)Material: 701065765R02 BO-TOP 36504 Adult ECC Pack
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: -701065209R01
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 Pack Wake For Material: 701064867R01
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 ECC Large Children's Hospital Material: 701064560R01
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-TOP 48400 OR PACK Material: 701064327R01
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- (1) Material: 701063255R01 BEQ-TOP 25003 3/8 3/8 up to 7lpm (2) Material: 701063255R02 BEQ-TOP 25003 3/8 3/8 up to 7 lpm
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:701062473R01
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 28901 MCV INFANT ECC Material:701056771R01
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 38300 ADULT CPS QID Material:701055862R01
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 5210 ECC Set - Respiratory Material: 701055604R01
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- (1) Material: 701055490R01 BEQ-TOP 15801 ¿ inch ECC Pack (2) Material :701055490R02 BEQ-TOP 15801 1/4 in ECC Pack
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 37200 E-Circuit Bioline Heparin Material: 701055388R01
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-TOP 13901 Rapid Response Universal Pk Material: 701054874R01
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 9004 1/4 Custom Pk w/RF32 & HMOD Material: 701054451R01
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 32100 Adult Custom Pack Material:701054438R01
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 27700 Quadrox iD Pack Material: 701054389R02
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 24202 ADULT ECC Material: 701054295R01
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: (1) Material: 701053941R01 BEQ-TOP 9005 3/8 Custom Pk w/RF32 & HMOD (2) Material: 701053941R02- BEQ-TOP 9005 3/8 Custom Pk w RF32 & HMOD Material:
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 250011/4 1/4 Less than 20 kg up Material: 701053906R01
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-TOP 20705 SMALL PATIENT 1/4 Material: 701053486R01
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 32200 ECC Pack Material: 701053319R01
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 25500 ECC 3/8 in AV Loop w Qx-iD Material: 701052461R01
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 28601 NEONATE ECC QPiD Material: 701051935R01
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 5502 ECC Pack Material:701051791R01
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 15704 Circulatory Circuit 3/8" Material:701050859R01
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-TOP 15200 OR PACK HMO & RF Material:701050647R01
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 5900 TCH 3/8 Quadrox-iD Pack Material:701050228R01
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 24101 Adult ECC Pack Material:701050177R01
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 24100 Small Patient ECC Pack Material:701050175R02
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 21502 ECC Quadrox iD w/RF 3/8" Material:701050060R01
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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