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Infusion Pumps

🏥 Medical Devices • 4,262 recalls

CervAlign Anterior Cervical Plate System-Cervalign, 3 Level, 42mm Material Number: 66-342 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

Class I - Dangerous

Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision

Jan 15, 2021 Infusion Pumps Nationwide View Details →

CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 36mm Material Number: 66-236 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

Class I - Dangerous

Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision

Jan 15, 2021 Infusion Pumps Nationwide View Details →

CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 42mm Material Number: 66-242 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

Class I - Dangerous

Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision

Jan 15, 2021 Infusion Pumps Nationwide View Details →

CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 12mm Material Number: 66-112 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

Class I - Dangerous

Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision

Jan 15, 2021 Infusion Pumps Nationwide View Details →

CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 14mm Material Number: 66-114 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

Class I - Dangerous

Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision

Jan 15, 2021 Infusion Pumps Nationwide View Details →

PHYSIO CONTROL LIFEPAK CR2 Defibrillator 3321605-xxx The LIFEPAK CR2 defibrillator is designed for indoor and outdoor use in a stationary environment. After the electrode pads are applied, the fully automatic model evaluates the heart rhythm and, if a shockable rhythm is detected, delivers a shock without any responder assistance. The LIFEPAK CR2 defibrillator is indicated for use on patients 1 year of age or older in cardiopulmonary arrest.

Physio-Control

Class I - Dangerous

Due to complaints received regarding missing lid magnets which may result in premature battery depletion.

Jan 14, 2021 Infusion Pumps Nationwide View Details →

CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 40mm Material Number: 66-240 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

Class I - Dangerous

Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision

Jan 15, 2021 Infusion Pumps Nationwide View Details →

CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 34mm Material Number: 66-234 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

Class I - Dangerous

Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision

Jan 15, 2021 Infusion Pumps Nationwide View Details →

CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 24m Material Number: 66-124 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

Class I - Dangerous

Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision

Jan 15, 2021 Infusion Pumps Nationwide View Details →

CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 85mm Material Number: 66-585 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

Class I - Dangerous

Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision

Jan 15, 2021 Infusion Pumps Nationwide View Details →

CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 84mm Material Number: 66-484 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

Class I - Dangerous

Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision

Jan 15, 2021 Infusion Pumps Nationwide View Details →

CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 26mm Material Number: 66-226 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

Class I - Dangerous

Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision

Jan 15, 2021 Infusion Pumps Nationwide View Details →

SUNSTAR G.U.M. HYDRAL DRY MOUTH RELIEF On-the-go Oral Spray, 2 FL.OZ. UPC0 70942 30713 0 - Product Usage: The device is formulated with water, moisturizers /humectants including one plant-based moisture rich humectant, sweeteners and flavors that collectively have lubricating, moisturizing, soothing, and refreshing properties to help relieve and manage the symptoms of dry mouth.

Sunstar Americas

Class I - Dangerous

The product may be contaminated with Burkholderia cepacia

Feb 18, 2021 Infusion Pumps Nationwide View Details →

CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 32mm Material Number: 66-232 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

Class I - Dangerous

Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision

Jan 15, 2021 Infusion Pumps Nationwide View Details →

CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 16mm Material Number: 66-116 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

Class I - Dangerous

Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision

Jan 15, 2021 Infusion Pumps Nationwide View Details →

CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 105mm Material Number: 66-5105 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

Class I - Dangerous

Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision

Jan 15, 2021 Infusion Pumps Nationwide View Details →

Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares. Outer box UPN, Inner Pouch UPN: M00561311 (Box 10), M00561310 M00562301 (Box 10), M00562300; M00562321 (Box 10), M00562320; M00562341 (Box 10), M00562340; M00562451 (Box 10), M00562450; M00562401 (Box 10), M00562400; M00562402 (Box 40), M00562400; M00562422 (Box 40), M00562420; M00562471 (Box 10), M00562470.

Boston Scientific

Class I - Dangerous

Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient.

Jan 19, 2021 Infusion Pumps Nationwide View Details →

Captivator/Captiflex/Sensation Short Throw Single-Use Polypectomy Snares Outer box UPN, Inner pouch UPN: M00560311 (Box 5), M00560310; M00560321 (Box 5), M00560320; M00562651 (Box 5), M00562650; M00562652 (Box 20), M00562650; M00562671 (Box 5), M00562670; M00562672 (Box 20), M00562670; M00562673 (Box 40), M00562670; M00562691 (Box 5); M00562690; M00562692 (Box 20), M00562690; M00562693 (Box 40), M00562690.

Boston Scientific

Class I - Dangerous

Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient.

Jan 19, 2021 Infusion Pumps Nationwide View Details →
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