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STERRAD 50, Product Code 10114. The STERRAD Cassettes are used on STERRAD Sterilization System...

FDA Device Recall #Z-0842-2015 — Class II — November 4, 2014

Recall Summary

Recall Number Z-0842-2015
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 50, Product Code 10114. 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

10050056174 10050021097 10050035006 10050035054 10050021012 10050035378 10050056170 10050035179 10050021050 10050035261 10050035388 10050021110 10050045549 10050035374 10050035338 10050045503 10050045613 10050035156 10050021060 10050000834 10050035172 10050035181 10050045569 10050035323 10050056188 10050056115 10050035141 10050000517 10050035284 10050045451 10050045404 10050021041 10050021111 10050000850 10050045478 10050010941 10050045603 10050056205 10050035392 10050000762 10050045429 10050000680 10050045491 10050056194 10050021049 10050000867 10050035173 10050056134 10050035387 10050056168 10050021149 10050035013 10050035159 10050035137 10050035100 10050035002 10050035121 10050056203 10050010945 10050010948 10050035287 10050045477 10050056165 10050045507 10050021032 10050035267 10050000712 10050045576 10050035061 10050045563 10050021145 10050045612 10050035143 10050035375 10050035174 10050045557 10050035188 10050021037 10050035330 10050056109 10050056116 10050021116 10050056166 10050000552 10050045494 10050056175 10050045614 10050021077 10050000554 10050021054 10050056145 10050000872 10050000532 10050000621 10050056138 10050056154 10050010952 10050035066 10050000858 10050035337

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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