Overview of recall records associated with Smiths Medical Asd Inc., including dates, categories and classifications where available.
Classification mix: Class II: 119, Class I: 68, Class III: 6.
There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate…
There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate…
There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate…
There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate…
There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate…
The unit box is labeled with an incorrect expiration date (the manufacturing date of 3/17/2021) but the individual packaging contains the correct expiration date (3/17/2026).
The complaint involved the absence of a component called "ASM Filter-Pro ABG SYR CAP" from the packaging of Pro-Vent Arterial Blood Sampling (ABG) Kits. Specifically, this issue affected a…
A force sensor in the occlusion detector may drift out of calibration leading to increased occlusion detection times, false occlusion alarms, or a System Failure Alarm. If the force sensor…
A force sensor in the occlusion detector may drift out of calibration leading to increased occlusion detection times, false occlusion alarms, or a System Failure Alarm. If the force sensor…
A force sensor in the occlusion detector may drift out of calibration leading to increased occlusion detection times, false occlusion alarms, or a System Failure Alarm. If the force sensor…
A force sensor in the occlusion detector may drift out of calibration leading to increased occlusion detection times, false occlusion alarms, or a System Failure Alarm. If the force sensor…
A force sensor in the occlusion detector may drift out of calibration leading to increased occlusion detection times, false occlusion alarms, or a System Failure Alarm. If the force sensor…
A force sensor in the occlusion detector may drift out of calibration leading to increased occlusion detection times, false occlusion alarms, or a System Failure Alarm. If the force sensor…
DuraLife devices instructions for cleaning and sterilization have been determined to be inadequate. Specifically, for the DuraLife product, the IFU does not provide the cleaning method,…
DuraLife devices instructions for cleaning and sterilization have been determined to be inadequate. Specifically, for the DuraLife product, the IFU does not provide the cleaning method,…
DuraLife devices instructions for cleaning and sterilization have been determined to be inadequate. Specifically, for the DuraLife product, the IFU does not provide the cleaning method,…
There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or Underdelivery related to Tubing Occlusion and (2) False "No Disposable Attached (NDA)" Alarms
There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or Underdelivery related to Tubing Occlusion and (2) False "No Disposable Attached (NDA)" Alarms
There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or Underdelivery related to Tubing Occlusion and (2) False "No Disposable Attached (NDA)" Alarms
There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or Underdelivery related to Tubing Occlusion and (2) False "No Disposable Attached (NDA)" Alarms
There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or Underdelivery related to Tubing Occlusion and (2) False "No Disposable Attached (NDA)" Alarms
Potential for delay in sending Infusion Start Messages to third-party Electronic Health Record systems which may affect infusion auto-programming on the pump and documentation
Multiple issues with the potential for interruption of therapy or over-infusion: 1. Primary Audible Alarm (PAA), 2. Unanticipated Depleted Battery Alarms, 3. Time Base Alarm, 4.…
Multiple issues with the potential for interruption of therapy or over-infusion: 1. Primary Audible Alarm (PAA), 2. Unanticipated Depleted Battery Alarms, 3. Time Base Alarm, 4.…
This page summarizes recall records in which the official source identifies Smiths Medical Asd Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.
