Indicator, Physical/chemical Sterilization Process

Terragene Integron IT26-C

Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products.

3M Attest Steam Chemical Integrators, REF 1243A

3M Attest Steam Chemical Integrators with dates of manufacture between November 6, 2022 and January 17, 2023 have an increased potential to leak ink during a sterilization cycle.

3M Attest Steam Chemical Integrators, REF 1243B

3M Attest Steam Chemical Integrators with dates of manufacture between November 6, 2022 and January 17, 2023 have an increased potential to leak ink during a sterilization cycle.

a. SPS MEDICAL SUPPLY Steam Indicator Strip SPSmedical Sterilization Chemical Indicator Strip Steam 4 Inch Model Number: SIS-250.

Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

a. Comply INDICATOR, COMPLY VAPOR GAS (250/BG 4BG/CS) 3M Model Number: 1248.

Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

VERIFY SixCess 270FP Challenge Pack, STERIS Corporation, 5960 Heisley Road, Mentor, OH 44060, 440-354-2600.

STERIS has identified that the outer shipping package for one lot (Lot #024552A) of VERIFY SixCess Challenge Packs incorrectly identifies the lot as Lot #024522A.

Medline Med-Checks BI Test packs with Instant Readout Integrator, SteriTec Product Code PL 200, Distributor Product Code MDS200500IR

Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involving the EZTest Steam and Smart-Read Biological Indicators (BI) because the readout time is not in specification with the label claims.

Cardinal BI Stat Biological Test Pack with Instant Readout Integrator, SteriTec Product Code PL 160/A, Distributor Product Code T40311PE

Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involving the EZTest Steam and Smart-Read Biological Indicators (BI) because the readout time is not in specification with the label claims.

Verify SixCess Indicator Strips, Model #: PCC005, PCC006, PCC007, PCC008, PCC031, PCC033, PCC034, PCC037 & PCC038, Mfr. By: Albert Browne, LTD, Chancery House

During an inspection the firm was notified that language contained in labeling and promotional literature directs Customers that the products can be used to replace biological indicators and/or release loads containing implants.

Verify SixCess Challenge Pack, Model #'s: LCC003, LCC005, LCC014 & LCC310, Mfr. By: Albert Browne, LTD, Chancery House 190 Waterside Rd. Hamilton Industrial Pa

During an inspection the firm was notified that language contained in labeling and promotional literature directs Customers that the products can be used to replace biological indicators and/or release loads containing implants.