Getinge 86-Series-Medical Washer-Disinfector Part Number: S-86682003 Product Usage: The Getinge 86 Series Medical Washer-Disinfector is designed for use in healthcare facilities and laboratories where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.
This recall has been terminated (originally issued May 20, 2019).
- Recall Initiated
- May 20, 2019
- Terminated
- December 15, 2023
- Recall Number
- Z-1778-2019
- Quantity
- 40 units
- Firm Location
- Wayne, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
Possibility that inlet pump hose of the Washer Disinfector Getinge 86-Series (S-8666, S-8668) might collapse during use result in low water pressure within the circulation system and, in the worst case scenario, can result in the contents of the Washer Disinfector not being cleaned properly after finished process.
Distribution
Worldwide Distribution - US Nationwide GA, IL, IN, MI, NC, OR, PA, VA Foreign: Australia, Canada, China, France, Germany, India, Japan, Korea, Netherlands, Saudi Arabia, South Africa, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, Ukraine
Lot / Code Info
Serail Numbers: WAA088623 WAA088625 WAA088637 WAA088639 WAA088686 WAA088775 WAA088776 WAA088777 WAA088819 WAA088825 WAA088866 WAA088894 WAA088917 WAA088948 WAA088949 WAA088950 WAA088951 WAA089058 WAA089060 WAA089123 WAA089137 WAA089138 WAA089141 WAA089143 WAA089201 WAA089247 WAA089251 WAA089262 WAA089269 WAA089295 WAA089298 WAA089323 WAA089327 WAA089334 WAA089337 WAA089350 WAA089363 WAA089416 WAA089436 WAA089649
Root Cause
Nonconforming Material/Component
Action Taken
Getinge issued a An Urgent Medical Device Correction to U.S. consignees on 5/20/19 via FedEx 2 day Delivery with Signature Proof of Delivery (SPOD). Letter provides identification of the issue, health risk and action to take: examine your inventory immediately, Until the required correction has been completed, take the following precautions detailed in the User Manual: Do not operate the machine unattended. Always inspect the processed goods after a wash cycle. Contact a Getinge Service person if either of these are noticed: o If the washer starts to sound different than usual during a wash cycle, abort the process and call your service person.o Goods are not cleaned after the process is finished. Getinge Service person will contact the person you listed on the Customer Response Form to schedule service for an update of your device, free of charge. You can also arrange a visit by a Getingetrained or authorized service technician by calling Getinge Customer Support at 18009509912 (select option 1). Customer Service hours: 8:00 AM to 5:00 PM (EST) Monday to Friday