DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)
Medtronic Perfusion Systems
Class I - Dangerous
Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
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Other Medical Devices
🏥 Medical Devices • 15,203 recalls
Class I - Dangerous
Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging.
Class I - Dangerous
Potential for hole in package compromising sterility of the medical kit.
Class I - Dangerous
Potential for hole in package compromising sterility of the medical kit.
Class I - Dangerous
Potential for hole in package compromising sterility of the medical kit.
Class I - Dangerous
Lack of 510(k) clearance.
BD Pyxis MedStation 4000 Main, REF 303
CareFusion 303
Class I - Dangerous
Drawer and/or door failures that may lead to a delay in access to medications. The following three situations in which drawer and/or door failures may occur have been identified: Situation 1: Door Latch Failure, Situation 2: Cable Ribbon Damage, Situation 3: Magnet Falling Out,
Class I - Dangerous
Lack of 510(k) clearance.
Bodor P and C series laser cutting machines
Jinan Bodor Cnc Machine Co
Class I - Dangerous
Non-compliant laser products
BD Pyxis Med 4000 Auxiliary (AUX), REF 314
CareFusion 303
Class I - Dangerous
Drawer and/or door failures that may lead to a delay in access to medications. The following three situations in which drawer and/or door failures may occur have been identified: Situation 1: Door Latch Failure, Situation 2: Cable Ribbon Damage, Situation 3: Magnet Falling Out,
BD Pyxis MedStation ES (Med ES Main), REF 323
CareFusion 303
Class I - Dangerous
Drawer and/or door failures that may lead to a delay in access to medications. The following three situations in which drawer and/or door failures may occur have been identified: Situation 1: Door Latch Failure, Situation 2: Cable Ribbon Damage, Situation 3: Magnet Falling Out,
Baxter Solution Set with Duo-Vent Spike, REF 2R8404
Baxter Healthcare
Class I - Dangerous
Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable.
Baxter Clearlink System Solution Set with Duo-Vent Spike, REF 2R8538
Baxter Healthcare
Class I - Dangerous
Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable.
Class I - Dangerous
Lack of 510(k) clearance.
EOPA Arterial Cannula, Model Numbers 77422 (22 Fr) and 77418 (18 Fr)
Medtronic Perfusion Systems
Class I - Dangerous
Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
BD Pyxis MedStation 4000 AUX, REF 306
CareFusion 303
Class I - Dangerous
Drawer and/or door failures that may lead to a delay in access to medications. The following three situations in which drawer and/or door failures may occur have been identified: Situation 1: Door Latch Failure, Situation 2: Cable Ribbon Damage, Situation 3: Magnet Falling Out,
Class I - Dangerous
Potential for hole in package compromising sterility of the medical kit.
As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurate pulmonary artery (PA) pressure readings.
As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurate pulmonary artery (PA) pressure readings.
Class I - Dangerous
Due to incompatibility of bone tamp (Rev A) and bone funnels (Rev C).