EVOTECH Endoscope Cleaner and Reprocessor System 208V, Product Code: 50004 The EVOTECH ECR End...
FDA Device Recall #Z-0965-2017 — Class II — September 27, 2016
Recall Summary
| Recall Number | Z-0965-2017 |
| Classification | Class II — Moderate risk |
| Date Initiated | September 27, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Advanced Sterilization Products |
| Location | Irvine, CA |
| Product Type | Devices |
| Quantity | 107 units |
Product Description
EVOTECH Endoscope Cleaner and Reprocessor System 208V, Product Code: 50004 The EVOTECH ECR Endoscope Cleaner and Reprocessor, a washer/disinfector, is indicated for use with high-level disinfectant CIDEX OPA Concentrate Solution and an enzymatic detergent (CIDEZYME XTRA) to achieve cleaning and high level disinfection of heat sensitive (>60¿C} semi-critical endoscopes.
Reason for Recall
Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor System because the hose may come loose and cause a leak.
Distribution Pattern
US Nationwide Distribution.
Lot / Code Information
UDI 10705037030958 Serial No. 5041150187 UDI 10705037030958 Serial No. 5041150188 UDI 10705037030958 Serial No. 5041150189 UDI 10705037030958 Serial No. 5041150192 UDI 10705037030958 Serial No. 5041150191 UDI 10705037030958 Serial No. 5041150190 UDI 10705037030958 Serial No. 5041150193 UDI 10705037030958 Serial No. 5041150205 UDI 10705037030958 Serial No. 5041150212 UDI 10705037030958 Serial No. 5041150207 UDI 10705037030958 Serial No. 5041150213 UDI 10705037030958 Serial No. 5041150206 UDI 10705037030958 Serial No. 5041150204 UDI 10705037030958 Serial No. 5041150210 UDI 10705037030958 Serial No. 5041150198 UDI 10705037030958 Serial No. 5041150228 UDI 10705037030958 Serial No. 5041150230 UDI 10705037030958 Serial No. 5041150229 UDI 10705037030958 Serial No. 5041150227 UDI 10705037030958 Serial No. 5041150226 UDI 10705037030958 Serial No. 5041150209 UDI 10705037030958 Serial No. 5041150231 UDI 10705037030958 Serial No. 5041150197 UDI 10705037030958 Serial No. 5041150236 UDI 10705037030958 Serial No. 5041150211 UDI 10705037030958 Serial No. 5041150235 UDI 10705037030958 Serial No. 5041150233 UDI 10705037030958 Serial No. 5041150234 UDI 10705037030958 Serial No. 5041150232 UDI 10705037030958 Serial No. 5041150196 UDI 10705037030958 Serial No. 5041150195 UDI 10705037030958 Serial No. 5041150199 UDI 10705037030958 Serial No. 5041150194 UDI 10705037030958 Serial No. 5041150202 UDI 10705037030958 Serial No. 5041150245 UDI 10705037030958 Serial No.5041150248 UDI 10705037030958 Serial No. 5041150246 UDI 10705037030958 Serial No. 5041150241 UDI 10705037030958 Serial No. 5041150247 UDI 10705037030958 Serial No. 5041150240 UDI 10705037030958 Serial No. 5041150242 UDI 10705037030958 Serial No. 5041150208 UDI 10705037030958 Serial No. 5041150239 UDI 10705037030958 Serial No. 5041150238 UDI 10705037030958 Serial No. 5041150237 UDI 10705037030958 Serial No. 5041150203 UDI 10705037030958 Serial No. 5041150200 UDI 10705037030958 Serial No. 5041150201 UDI 10705037030958 Serial No. 5041150244 UDI 10705037030958 Serial No. 5041150243 UDI 10705037030958 Serial No. 5041150251 UDI 10705037030958 Serial No. 5041150252 UDI 10705037030958 Serial No. 5041150250 UDI 10705037030958 Serial No. 5041150288 UDI 10705037030958 Serial No. 5041150290 UDI 10705037030958 Serial No. 5041150280 UDI 10705037030958 Serial No. 5041150253 UDI 10705037030958 Serial No. 5041150249 UDI 10705037030958 Serial No. 5041150254 UDI 10705037030958 Serial No. 5041150255 UDI 10705037030958 Serial No. 5041150282 UDI 10705037030958 Serial No. 5041150285 UDI 10705037030958 Serial No. 5041150286 UDI 10705037030958 Serial No. 5041150292 UDI 10705037030958 Serial No. 5041150287 UDI 10705037030958 Serial No. 5041150284 UDI 10705037030958 Serial No. 5041150289 UDI 10705037030958 Serial No. 5041150293 UDI 10705037030958 Serial No. 5041150302 UDI 10705037030958 Serial No. 5041150291 UDI 10705037030958 Serial No. 5041150301 UDI 10705037030958 Serial No. 5041150304 UDI 10705037030958 Serial No. 5041150305 UDI 10705037030958 Serial No. 5041150283 UDI 10705037030958 Serial No. 5041150328 UDI 10705037030958 Serial No. 5041150326 UDI 10705037030958 Serial No. 5041150306 UDI 10705037030958 Serial No. 5041150323 UDI 10705037030958 Serial No. 5041150324 UDI 10705037030958 Serial No. 5041150307 UDI 10705037030958 Serial No. 5041150310 UDI 10705037030958 Serial No. 5041150321 UDI 10705037030958 Serial No. 5041150320 UDI 10705037030958 Serial No. 5041150322 UDI 10705037030958 Serial No. 5041150303 UDI 10705037030958 Serial No. 5041150311 UDI 10705037030958 Serial No. 5041150308 UDI 10705037030958 Serial No. 5041150327 UDI 10705037030958 Serial No. 5041150325 UDI 10705037030958 Serial No. 5041150329 UDI 10705037030958 Serial No. 5041150330 UDI 10705037030958 Serial No. 5041150331 UDI 10705037030958 Serial No. 5041150333 UDI 10705037030958 Serial No. 5041150334 UDI 10705037030958 Serial No. 5041150341 UDI 10705037030958 Serial No. 5041150342 UDI 10705037030958 Serial No. 5041150343 UDI 10705037030958 Serial No. 5041150344 UDI 10705037030958 Serial No. 5041150345 UDI 10705037030958 Serial No. 5041150346 UDI 10705037030958 Serial No. 5041150347 UDI 10705037030958 Serial No. 5041150348 UDI 10705037030958 Serial No. 5041150349 UDI 10705037030958 Serial No. 5041150350 UDI 10705037030958 Serial No. 5041160377
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-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 |
| Z-1715-2015 | Class II | EVOTECH Endoscope Cleaner and Reprocessing Syst... | May 11, 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.