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.

Class I - Dangerous

🏥 Medical Devices Recalled: September 27, 2016 Advanced Sterilization Products Infusion Pumps Nationwide

What Should You Do?

Check if you have this product:
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
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Advanced Sterilization Products
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.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full 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.

Product Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0965-2017

Related Recalls

STERRAD NX Sterilization System, Product Code: 10033, 10033-002

Advanced Sterilization Products

Class I - Dangerous

Advanced Sterilization Products (ASP) has identified that in a rare sequence of events following an external power outage, the system door interlock can be become disengaged during system reboot for a 20-second duration.

Jan 9, 2017 Other Medical Devices Nationwide View Details →

CIDEX OPA Solution, P/N 20390 for use as a high level disinfectant for reprocessing heat sensitive medical devices.

Advanced Sterilization Products

Class I - Dangerous

Advanced Sterilization Products (ASP) is reminding all CIDEX OPA Solution customers to follow the warnings and rinsing procedure in their current labelling around the criticality of proper rinsing of medical device following disinfection with CIDEX OPA according to the CIDEX OPA Solution IFU (Instruction For Use).

Aug 10, 2015 Infusion Pumps View Details →

CIDEX Activated Dialdehyde Solution, 4 bottles/case, P/N: 2266

Advanced Sterilization Products

Class I - Dangerous

Advanced Sterilization Products (ASP) is recalling the CIDEX Activated Dialdehyde Solution because it may lack the adequate data to support the entire 24-month shelf life.

Jul 27, 2015 Infusion Pumps Nationwide View Details →