Core noun
Device recall evidence
Joined enrichment rows that support device recall linkage and root-cause wording.
Indexed record set
39,516 evidence rows
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- Evidence
- device-recall:cfres:152970
- Product
- Micropuncture Check-Flo Performer Introducer Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. Introducers are intended for introduction of balloons, closed and non-tapered end catheters or other diagnostic and interventional devices
- Join
- Official recall number ·
Z-1391-2017 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:152891
- Product
- Lumbar Laminectomy Pack, part number AMS2501 Lumbar Laminectomy Pack, part number AMS2501(A Lumbar Laminectomy Pack, part number AMS2501(B
- Join
- Official recall number ·
Z-1336-2017 - Root cause
- Nonconforming Material/Component
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- Evidence
- device-recall:cfres:152921
- Product
- Set Up Pack, part number PSS3574(A
- Join
- Official recall number ·
Z-1366-2017 - Root cause
- Nonconforming Material/Component
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- Evidence
- device-recall:cfres:152907
- Product
- Opgrande Hand Pack, part number AMS4767
- Join
- Official recall number ·
Z-1352-2017 - Root cause
- Nonconforming Material/Component
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- Evidence
- device-recall:cfres:152845
- Product
- Facial Tray, part number PSS1558(A
- Join
- Official recall number ·
Z-1302-2017 - Root cause
- Nonconforming Material/Component
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- Evidence
- device-recall:cfres:152831
- Product
- D&C/Cysto Pack, part number PSS3257(D
- Join
- Official recall number ·
Z-1289-2017 - Root cause
- Nonconforming Material/Component
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- Evidence
- device-recall:cfres:152936
- Product
- Vein Tray, part number AMS6312
- Join
- Official recall number ·
Z-1381-2017 - Root cause
- Nonconforming Material/Component
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- Evidence
- device-recall:cfres:153231
- Product
- Remel, Haemophilus Test Medium (Agar) in A) 100 mm REF R01503, and B) 150 mm plates REF R04033,
- Join
- Official recall number ·
Z-1400-2017 - Root cause
- Nonconforming Material/Component
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- Evidence
- device-recall:cfres:152953
- Product
- A-series lift - A625 Manual w/Load Cell & Wi-Fi, Omni Part No. 324124. Prism Medical.
- Join
- Official recall number ·
Z-1405-2017 - Root cause
- Device Design
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- Evidence
- device-recall:cfres:152929
- Product
- Total Joint Pack, part number 006358-6
- Join
- Official recall number ·
Z-1374-2017 - Root cause
- Nonconforming Material/Component
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- Evidence
- device-recall:cfres:152589
- Product
- The LIFEPAK 1000 defibrillator is intended for use by personnel who are authorized by a physician/medical director and are trained in CPR and the use of the LIFEPAK 1000 defibrillator.
- Join
- Official recall number ·
Z-1257-2017 - Root cause
- Device Design
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- Evidence
- device-recall:cfres:152792
- Product
- Arthroscopy Pack, part number AMS6559
- Join
- Official recall number ·
Z-1262-2017 - Root cause
- Nonconforming Material/Component
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- Evidence
- device-recall:cfres:152631
- Product
- Abdominoplasty Pack, Part numbers AMS3326(B, AMS4381, and AMS4381(B.
- Join
- Official recall number ·
Z-1258-2017 - Root cause
- Nonconforming Material/Component
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- Evidence
- device-recall:cfres:152798
- Product
- Basic Extended Pack, part number AMS4421(A Basic Extended Pack, part number AMS4421(B
- Join
- Official recall number ·
Z-1264-2017 - Root cause
- Nonconforming Material/Component
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- Evidence
- device-recall:cfres:152930
- Product
- Total Knee Pack (15710), part number AMS6563
- Join
- Official recall number ·
Z-1375-2017 - Root cause
- Nonconforming Material/Component
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- Evidence
- device-recall:cfres:152928
- Product
- Total Hip Pack, part number PSS2956
- Join
- Official recall number ·
Z-1373-2017 - Root cause
- Nonconforming Material/Component
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- Evidence
- device-recall:cfres:153360
- Product
- L-Varlock Cage/Trial Implant Holder, Reference HD0060, Kisco International, France. Product Usage: The L-Varlock Lumbar Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). L-Varlock Lumbar implants are to be used with autogenous bone graft and implanted via an open posterior approach. L-Varlock Lumbar implant is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
- Join
- Official recall number ·
Z-1461-2017 - Root cause
- Process control
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- Evidence
- device-recall:cfres:152971
- Product
- Check-Flo Introducer Hausdorf-Lock Atrial, Individual product is packaged in a Tyvek-film sterilizable outer pouch. Introducers are intended for introduction of balloons, closed and non-tapered end catheters or other diagnostic and interventional devices
- Join
- Official recall number ·
Z-1392-2017 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:152884
- Product
- Laparoscopy Pack (1184), part number AMS6562
- Join
- Official recall number ·
Z-1331-2017 - Root cause
- Nonconforming Material/Component
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- Evidence
- device-recall:cfres:149193
- Product
- SENSAR Foldable IOL with OptiEdge Design, Model No. AR40e The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag.
- Join
- Official recall number ·
Z-2855-2016 - Root cause
- Process control
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- Evidence
- device-recall:cfres:148451
- Product
- ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA21, SIZE 2+; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 2 FEMUR & SIZE 2 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee Systems are indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: 1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.
- Join
- Official recall number ·
Z-2696-2016 - Root cause
- Use error
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- Evidence
- device-recall:cfres:148940
- Product
- TP4 Kit with 10cc SafeSet Reservoir, Needleless Valve, Filter Millex and Admin Set, Item No. 46104-65 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.
- Join
- Official recall number ·
Z-2825-2016 - Root cause
- Process control
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- Evidence
- device-recall:cfres:148904
- Product
- AirStrip Sense4Baby Model C Fetal Monitor The Sense4Baby System Model C is indicated for monitoring of maternal and fetal physiologic parameters during the antepartum period. The Sense4Baby System is to be used by health care professionals or patients, by prescription or doctor s order, in hospitals, clinics, physicians offices, antepartum rooms, or outside a hospital or health care setting. The data interpretation is to be done by a health care professional.
- Join
- Official recall number ·
Z-2829-2016 - Root cause
- Nonconforming Material/Component
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- Evidence
- device-recall:cfres:148914
- Product
- Transpac IV Trifurcated Monitoring Kit with SafeSet Reservoir and 2 Blood Sampling Ports, 84", 3.3mL Squeeze Flushes, 3 Disposable Transducers, Macrodrip (Pole Mount), Item No. 42650-06 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.
- Join
- Official recall number ·
Z-2812-2016 - Root cause
- Process control
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- Evidence
- device-recall:cfres:148915
- Product
- Transpac IV Trifurcated Monitoring Kit with 84" SafeSet Reservoir, 03 ml Squeeze Flush and Needleless Valves, Item No. 42650-66 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.
- Join
- Official recall number ·
Z-2813-2016 - Root cause
- Process control