Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC Kit REF ASK-45854-PUPM1 UDI code: (01)10801902159578(17)270531(11)251205(10)33F25M0011 The Arrowg+ard technology is intended to provide protection against catheter-related bloodstream infections (CRBSIs). It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use (> 30 days). Clinical effectiveness of the Arrowg+ard Blue Plus catheter in preventing CRBSIs compared to the original Arrowg+ard Blue¿ catheter has not been studied
Product Code: ASK-45854-PUPM1 UDI code: (01)10801902159578(17)270531(11)251205(10)33F25M0011 Batch Number: 33F25M0011 Product Code: ASK-45703-MGH UDI code: (01)10801902223675(17)261231(11)251209(10)33F25L0143 Batch Number: 33F25L0143 Product Code: ASK-42854-MGH UDI code: (01)10801902223668(17)261231(11)251210(10)33F25L0144 Batch Number: 33F25L0144 Product Code: ASK-45854-MGH UDI code: (01)10801902223699(17)261231(11)251209(10)33F25L0145 Batch Number: 33F25L0145
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.