Recall for CircuCool™ Tubing Set, Boston Scientific
2010.12.14
Product group Medical electronics / Electromedical devices
Reference 04511/10
Boston Scientific is conducting a Medical Device Recall on CircuCool Tubing Sets used with the Chilli II Cooled Ablation System. Certain packaging inconsistencies related to the tubing kit pouch material were observed. It was determined that the potential for a sterile barrier breach may exist which could compromise device sterility.
Only the material listed in the table below is affected:
CircuCool tubing Set Material N°(UPN): M0043521040
Lot/Batch Number: 61035169, 61071543, 61066975, 61066976, 61088879, 61088880, 61088881, 61088882, 61090636.
Recall for CircuCool™ Tubing Set, Boston Scientific , Download_VeroeffentlichtAm_EN