About the Recall:
The Membrane Changers (REF: MC, MC-R and MC-I) are used to change the membranes on your V-Sign™ 2 or OxiVenT™ sensors. This is part of routine maintenance as outlined in the Instruction Manuals (HB-005771-r, HB-011077-_, HB-005147-m, HB-006417-d). What is the defect? During the manufacturing process there were components that required rework and during this step, but before assembly, an additional piece of material may have been left in the device itself. This material is less than 0.5 mm in diameter and is inert and non-toxic. The source of this material has been identified, and Sentec AG can with certainty list the affected production lots. How does this manifest itself? As a result of the non-conformity, some membranes that are changed (using affected products) may have this non-conforming material under the new membrane on the sensor surface. This is easily observable and corrected by following the instructions for use in Appendix I.
Specific products(s) numbers/models that are affected:
Lots affected: Product Name Membrane Changer Reloadable Membrane Changer Insert Membrane Changer Single-Use Product Code MC-R MC-I MC # affected products 3 Changers each 5 Inserts each 3 Changers each Affected Lot Numbers 230894 230889 230698 230662 230650 230638 230556 230526 230521 230480 230474 230461 230375 230356 230351 230235 230083 230053 230043 230008 230005 225253 225221 225122 230920 230899 230898 230751 230750 230747 230744 230736 230733 230660 230651 230648 230644 230643 230642 230636 230605 230554 230553 230543 230536 230522 230512 230500 230964 230916 230905 230877 230855 230738 230735 230647 230640 230579 230541 230492 230470 230441 230224 230209 230191 230185 230167 230165 230146 230125 230016 225261
Manufacturer Notice/Web Site:
Actions to be taken by customer/Patient:
The Instruction Manuals are provided with each product. You can also download the information at www.sentec.com/ifu.
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