Device Recall Sterrad CycleSure Biological Indicator

Lot# 002127, 003127, 005127, 006127, 007127, 008127, 009127, 010127, 011128, 012127, 013127, 014127, 015127, 016127, 018127, 019127, 020127, 021127, 023127, 024127, 025127, 026127, 027127, 028127, 030127, 031127, 032127, 033127, 034127, 035127, 036127, 037127, 038121, 038127 039127, 040127, 041121, 042127, 043127, 044127, 045121, 045127, 046127, 047127, 048127, 049127, 052127, 053121, 053127, 054127, 055121, 056127, 057127, 058127, 059127, 060127, 061127, 062121, 062127, 063127, 064127, 065127, 067127, 068127, 069121, 069127, 070127, 071127, 072127, 073127, 074127, 076121, 077127, 078127, 078128, 079127, 081127, 082127, 084127, 085127, 086121, 086127, 087127, 089127, 090127, 092127, 093121, 094127, 095127, 100121, 100127, 101127, 102127, 104127, 107121, 107127, 107128, 109127, 109128, 110127, 111127, 114121, 114127, 118127, 121121, 121127, 123127, 124127, 125127, 128121, 128127, 129127, 130127, 131127, 132127, 135121, 135127, 136127, 137127, 138127, 139127, 142121, 142127, 143127, 144127, 145127, 146127, 150121, 150127, 151127, 152127, 152128,156127, 157127, 158127, 159127, 160127, 163127, 164127,165127, 339117, 340117, 341117, 342117, 343117, 344117, 345117, 346117, 347117, 348117, 349117, 350117, 351117, 352117, 353117, 354117, 355117, 357117, 360117, 362117, 363117, 364117.

General Hospital and Personal Use Devices

2

No

Worldwide Distribution - USA (nationwide)

STERRAD Cyclesure Biological Indicator (BI), P/N 14324 are sold in cases, packaged as part of STERRAD System Validation kits and STERRAD test packs. || The STERRAD CYCLESURE 24 Biological Indicator (BI), P/N 14324 is intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles.

Batch/Lot No.  14913706 15013706 15413706 15413106 15513706 15613706 15713706 15913706 16113706 16113106 16213706 16413706 16413806 16613706 16813706 16813806 16913706 17113706 17213706 17513706 17613706 17713706 17813706 17913706 18013706 18313706 18413706 18913706 19013706 19113706 19213706 19313706 19613706 19713706 19813706 19913706 20013706 20113706 20313706 20413706 20613706 20713706 20813706 21113706 21213706 21313706 21413706 21513706 21513806 21713706 21813706 21913706 22013706 22113706 22213706 22413706 22513706 22613706 22713706 22813706 22913706 23113706 23113806 23213706 23313706 23413706 23513706 23813706 23913706 24013706 24113706 24513706 24813106 24913706 25313106 25613106 26113106 26613106 26813106 27313106 27513106 28713106 28913106 29513106 30113106

General Hospital and Personal Use Devices

2

No

Worldwide Distribution.

STERRAD Cyclesure Biological Indicator (BI, Part No. 14324. || Intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles.