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STERRAD Cyclesure Biological Indicator (BI), P/N 14324 are sold in cases, packaged as part of STE...

FDA Device Recall #Z-2100-2012 — Class II — June 28, 2012

Recall Summary

Recall Number Z-2100-2012
Classification Class II — Moderate risk
Date Initiated June 28, 2012
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Advanced Sterilization Products
Location Irvine, CA
Product Type Devices
Quantity 38,693 units

Product Description

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.

Reason for Recall

Advanced Sterilization Products (ASP) is recalling certain lots of the STERRAD CYCLESURE 24 Biological Indicator (BI) product because it does not have adequate data to support the entire duration of the product's labeled shelf-life.

Distribution Pattern

Worldwide Distribution - USA (nationwide)

Lot / Code Information

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.

Other Recalls from Advanced Sterilization Products

Recall # Classification Product Date
Z-1197-2017 Class II STERRAD NX Sterilization System, Product Code: ... Jan 9, 2017
Z-0965-2017 Class II EVOTECH Endoscope Cleaner and Reprocessor Syste... Sep 27, 2016
Z-2774-2015 Class II CIDEX OPA Solution, P/N 20390 for use as a high... Aug 10, 2015
Z-2459-2015 Class II CIDEX Activated Dialdehyde Solution, 4 bottles/... Jul 27, 2015
Z-2375-2015 Class II Wall Chart for STERRAD 100NX System, P/N 10104.... Jul 17, 2015

Frequently Asked Questions

Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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