Public recall detail

Infusomat® Space Pump IV Set with Anti-Siphon Valve

2023-11-17

medium
Recall Safety notice
Quick summary

Quick summary: Infusomat® Space Pump IV Set with Anti-Siphon Valve. Date: 2023-11-17.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Infusomat® Space Pump IV Set with Anti-Siphon Valve. Date: 2023-11-17.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandB. Braun Medical Inc.
ProductInfusomat® Space Pump IV Set with Anti-Siphon Valve
IssueMedical devices - Device compatibility
Recall classType II
IdentificationRA-74606

Affected products

ProductInfusomat® Space Pump IV Set With Anti-Siphon Valve
Lotlot numbers lower than 0061902124
Model363901 363433 363420 363424 363904 363421 363423 363430 363410
Serial numberlot numbers lower than 0061902124
DescriptionInfusomat® Space Pump IV Set With Anti-Siphon Valve
ProductInfusomat® Space Pump Y-Type Blood IV Set With Anti-Siphon Valve
Lotlot numbers lower than 0061902124
Model363419
Serial numberlot numbers lower than 0061902124
DescriptionInfusomat® Space Pump Y-Type Blood IV Set With Anti-Siphon Valve
ProductInfusomat® Space Pump Low Adsorption IV Set With Anti-Siphon Valve
Lotlot numbers lower than 0061902124
Model363902
Serial numberlot numbers lower than 0061902124
DescriptionInfusomat® Space Pump Low Adsorption IV Set With Anti-Siphon Valve
ProductInfusomat® Space Pump Burette IV Set With Anti-Siphon Valve
Lotlot numbers lower than 0061902124
Model363032 363422
Serial numberlot numbers lower than 0061902124
DescriptionInfusomat® Space Pump Burette IV Set With Anti-Siphon Valve

Issue

In the identified lot number range of administration sets, the tubing outer diameter may vary in size. Additionally, the length of the tubing which contacts the air sensor may be too short resulting in the need to stretch the tubing to properly fit within the Infusomat® space pump. If the tubing is stretched or the tubing outer diameter is too small, this may result in suboptimal coupling between the administration set and the air-in-line sensor dampening the signal of the air-in-line sensor. If the signal is dampened, the Infusomat® space pump may generate false air-in-line alarms. Recall start date: October 23, 2023

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceGeneral public Healthcare Industry
CategoryHealth products - Medical devices - General hospital and personal use
CompaniesB. Braun Medical Inc. 824 12th Avenue, Bethlehem, Pennsylvania, United States, 18018
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-74606
Background{}
CompaniesB. Braun Medical Inc. 824 12th Avenue, Bethlehem, Pennsylvania, United States, 18018
AudiencesGeneral public Healthcare Industry
Source updated2023-11-17

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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