Public recall detail

Smiths Medical Rotators

2023-12-01

medium
Recall Safety notice
Quick summary

Quick summary: Smiths Medical Rotators. Date: 2023-12-01.

Recommended action

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

Recall details

Quick summary: Smiths Medical Rotators. Date: 2023-12-01.

Official details

Affected product details

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

BrandSmiths Medical Asd Inc.
ProductSmiths Medical Rotators
IssueMedical devices - Performance
Recall classType II
IdentificationRA-74658

Affected products

ProductAffected products
LotLot or serial number
ModelModel or catalog number
Serial numberLot or serial number
DescriptionAffected products
ProductRotating Adaptors
Lot4330826 4384397
ModelMX497HP
Serial number4330826 4384397
DescriptionRotating Adaptors
Product700PSI Stopcock W/ Rotator
Lot4355397 4380735 4387234
ModelMX433-1R
Serial number4355397 4380735 4387234
Description700PSI Stopcock W/ Rotator
Product48in (121.9cm) Injection Line Rotating Adapt (900PSI)
Lot4404698 4371082 4398429 4383431 4387987
ModelMX694R
Serial number4404698 4371082 4398429 4383431 4387987
Description48in (121.9cm) Injection Line Rotating Adapt (900PSI)
ProductPressure Transducers
Lot4387983 4383385 4392487
ModelMX20449 M20178R2
Serial number4387983 4383385 4392487
DescriptionPressure Transducers

Issue

Smiths Medical has identified a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the device's o-ring may be oversized affecting seal integrity. Recall Start Date: November 9, 2023

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Anaesthesiology Health products - Medical devices - General hospital and personal use
CompaniesSmiths Medical Asd, Inc. 6250 Shier Rings Rd, Dublin, Ohio, United States, 43016
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-74658
Background{}
CompaniesSmiths Medical Asd, Inc. 6250 Shier Rings Rd, Dublin, Ohio, United States, 43016
AudiencesHealthcare
Source updated2023-12-01

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

Official source Monitor products Back to recalls

Starting...

Related recalls

Similar recalls and safety notices.

Loading related recalls...