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Type of Product Medical Device
TGA Recall Reference RC-2016-RN-00422-1
Product Name/Description Papoose Infant Spine Immobilisers

Part Numbers Affected: PA-100, PAR-100 with replacement pads, PO-100 w/o P0 FRT, POR-100 w/o P0 FRT w/pad

Lot Numbers: before MX150727

ARTG Number: 135078
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 8/04/2016
Responsible Entity Ossur Australia - OA & Injury Solutions Pty Ltd
Reason/Issue Ossur has identified that the use of undeclared natural rubber latex in the leg (perineal) strap. Latex is a known allergen which can lead to allergic reactions in persons sensitive to latex. No injuries have been reported to date.
Recall Action Recall for Product Correction
Recall Action Instructions Ossur has replaced the affected product with unaffected stock.
This action has been closed-out on 11/11/2016.
Contact Information 1300 123 268 - Ossur Australia