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STERRAD 200, Product Code 10118 The STERRAD Cassettes are used on STERRAD Sterilization System...

FDA Device Recall #Z-0844-2015 — Class II — November 4, 2014

Recall Summary

Recall Number Z-0844-2015
Classification Class II — Moderate risk
Date Initiated November 4, 2014
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Advanced Sterilization Products
Location Irvine, CA
Product Type Devices
Quantity 19,978 units total (9,792 units in US)

Product Description

STERRAD 200, Product Code 10118 The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.

Reason for Recall

Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak indicator on the STERRAD System cassettes packaging may not function properly after exposure to hydrogen peroxide.

Distribution Pattern

Worldwide Distribution.

Lot / Code Information

10200050412 201080057 10200070902 10200080974 10200070758 10200070815 10200070925 201080046 10200070940 10200080949 201080052 10217040349 10200070827 10200040404 10200060693 201080075 10217000008 10217000013 10200070781 10200070824 217060639 200080955 10217050511 10200070782 10200080950 10200060679 10200060682 10200040436 10200070797 10200070844 10217050475 10200060660 10201050501 10200060683 200080996 201080055 10200080984 10200050506 201080040 217060618 10200050508 10200070894 10201060593 10200080976 10200070866 10217000014 10217050496 10200040359 10200050484 10200070791 10200070792 10200070890 10200040365 10200070891 10200050525 10200030329 10200060711 217010092 201080069 10200040379 10200070934 10200060709 10200070839 10200070859 10200060598 10200050519 10200070853 10200040334 217080023 10200070809 201080062 10200060661 10200060702 10200060750 10200070926 10201050524 201080039 201080076 10200070858 10200070892 10200060637 10217050510 10200050533 201080072 217100038 10200060688 200080995 10200080962 10200070897 10200060692 10200060738 201080035 10200070931 10200050536 10200060685 10200040401 10200070755 10217000003 217050373

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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