Reported Jun 18, 2014 · Terminated
HLD Systems Model 610 Washer/High Level Disinfector. Maximum weight of the Model 610 when filled with water is…
Cenorin, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cenorin, LLC · 6324 S 199th Pl Ste 107 · Kent, WA · 98032-2135
Is this the product you have?
- HLD Systems Model 610 Washer/High Level Disinfector. Maximum weight of the Model 610 when filled with water is approximately 450 pounds
- The dimensions of the system areWidth: 26.5" (67 cm)
- Depth33" (83 cm)
- Height46.5" (118 cm) to top of control panel; 64" (162.6 cm)- height clearance with lid open
- Product UsageUsage: This device washes reusable medical devices and disinfects them with high temperature hot water (pasteurization). The devices are washed with a cleaning solution (containing NaClO (sodium hypochlorite), surfactants, and detergents) to aid in the removal of debris and visible stains. Next, the medical devices and rinsed two times with water. The final, disinfection step uses only hot water at 160 F ¿ 2 F for 30 minutes
- Lot codes and dates
- 610601, 610603, 610703, 610704, 610705, 610707, 610708, 610802, 610803, 610804, 610901, 610903, 610904, 610905, 610902, 611001, 611002, 611004, 611102, 611103, 611201, 611202, 611203, 610902L, 611204. First two digits ( 61 ) refer to model number 610 for the HLD system Second two digits - two digit year of manufacture Last two digits sequentially numbered as they receive orders.
- Amount recalled
- 25 HLD systems
Where it was sold
- Nationwide
Why it was recalled
Cenorin LLC is voluntarily recalling HLD Systems Model 610 Washer/High Level Disinfector due to a potential risk of the system not injecting the proper amount of cleaning fluid during the wash cycle and not achieving the desired level of debris reduction.
This product could cause temporary or reversible health problems — stop using it.
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