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FDA (Device enforcement)Recalled 2016-09-27closedclass ii

Advanced Sterilization Products: EVOTECH Endoscope Cleaner and Reprocessor System 208V, Product Code: 50004 The EVOTECH ECR Endoscope Cleaner and Reprocessor, a washer/disinfector, is indicated for us

Is my product affected?

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

  • UPC 10705037030958

Check against the official notice below — it lists the full affected range.

What happened

Advanced Sterilization Products is recalling 107 units of the EVOTECH Endoscope Cleaner and Reprocessor System (208V, Product Code 50004) distributed nationwide in the United States. The washer/disinfector device is being recalled because the hose may come loose and cause a leak.

The affected units have a UDI of 10705037030958 and include multiple serial numbers ranging from 5041150187 through 5041150248 and beyond. The source document does not specify what action affected consumers should take in response to this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor System because the hose may come loose and cause a leak.

Details from the source

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: US Nationwide Distribution. Quantity: 107 units Lot/code info: 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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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