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-BEQ-TOP 22600 ECC QUADROX iD 3/8 Material:701049440R02
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 22600 ECC QUADROX ID 3 Material:701049440R01
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 17207 3/8" ECC Pack Material:701049346R01
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 5103 CPS Tubing Pack Material:701048690R01
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 8013 ECC QUADROX iD Pack RF32 Material:701047962R01
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 4932 Mercy Adaptation Pk Pediatric Material:709000520
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 31604 CHKD 1/4" ECC Material: 709000518
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 31603 CHKD 3/8" ECC Material: 709000516
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 48003 Rotaflow ONLY Support Pack Material:709000490
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 25503 TMC ¿ with BB & QiD Pedi Material:709000473
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 8075 S-Quadrox iD Plus Pack wRF3 Material: 709000460
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 48002 Bridge Kit Material: 709000444
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 25502 1/4 Better Bladder Material: 709000434
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 9410 Lurie Chldns Small 1/4 Material: 709000430
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 9409 Lurie Chlds Large 3/8 Material: 709000428
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 5220 UAB Hospital Accessory Material: 709000426
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 57000 Rotaflow Pack Material: 709000424
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 27602 709000417 Adult Custom Pack Material: 709000417
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 36507 Accessory Pk Mercy Material: 709000390
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 51502 Ochsner ECC Adult Pack Material: 709000385
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 25501 3/8" Better Bladder Pack Material: 709000370
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 4917 Mercy Medical Versa-Pack Material: 709000368
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 8030 4 in High Flow Pigtail Material: 709000366
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 5914 TCH ¿ Inch Change Kit Material: 709000334
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 5915 TCH 3/8 Inch Change Kit Material: 709000280
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 52301 ¿ Sash & Accessory Pack Material: 709000266
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 53400 Adaption Pack Material: 709000213
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 8506 Transport Pack Material: 709000146
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 46201 Small Pediatric Cardiac Surge Material: 709000133
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 52360 Cardioplegia Pack Material: 709000127
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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