Second Recall for Fem-Flex II Femoral Access Cannulae, Edwards Lifesciences
2009.07.08
Product group Injections / Infusions / Transfusions / Dialysis
Reference 00150/09
Second Recall of the products Fem-Flex II Femoral Access Cannulae (sizes 8 through 14 French, product codes and lots see annex) following the field safety notice (2/2009) from Edwards Lifesciences. The potential high patient risk is that the flow could be compromised during an open heart procedure and result in patient injury. Additionally, some packages of the Non-Duraflo coated cannulae (without heparin) may contain the Instructions for Use of the Duraflo coated cannulae.