| TGA Action ID |
RC-2025-RN-00722-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
RAINBOW DCIP PED REUSABLE SENSOR & M-LNCS PED ADHESIVE SENSOR
Lot Numbers: 23FMK, 23EQY
Catalogue Numbers: 11171-000050, 11171-000040
GTIN: 00843997004862, 00843997002523 |
| ARTG Number |
201980, 201981 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Stryker has identified two separate labelling discrepancies involving SpO2 sensors. These discrepancies are limited to the external shipping packaging and do not affect the individual product packaging or the performance of the products.
In one instance, Rainbow DCI Adult Reusable Sensors were incorrectly labelled by Stryker as Rainbow DCIP Pediatric Reusable Sensors. As a result, customers who ordered Rainbow DCIP Paediatric Reusable Sensors (catalog number/REF 11171-000050) may have received Rainbow DCI Adult Reusable Sensors from the affected lot.
In another case, the M-LNCS Paediatric Adhesive Sensor (catalog number/REF 11171-000040) was incorrectly labelled upon receipt as catalog number/REF 11140-000080. As a result, customers who ordered a power extension cable may have inadvertently received an M-LNCS Pediatric Adhesive Sensor from the affected lot numbers. |
| Instructions for Customers/Users |
Customers are to:
· Immediately review the Customer Notification Letter and quarantine any unopened affected product in their possession.
· Inform Stryker immediately if any affected product has been loaned, sold, or otherwise disposed of.
· Expect coordination from a Stryker representative regarding the return or replacement of affected products.
· Return products within scope to the manufacturer, as part of the proposed recall action. |
| Action Commencement Date |
20/08/2025 |
| Responsible Entity |
|
| Contact Information |
postmarketssp@stryker.com |