Food, drugs, devices › Cenorin, LLC
Device recall: HLD Systems 600 Series Washer/Pasteurizer, UDI (01) 0085249007009 (11) 160929 (21) 61160; Model 610HT, 115V & Model 610H
FDA enforcement event 80295 is a device recall by Cenorin, LLC of Kent, WA, initiated 9 Apr 2018 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 92% of the 1,074 device enforcement events initiated in 2018 carry the same class.
Status: Terminated, terminated 13 Sep 2019. Initiation: voluntary: firm initiated. Cenorin, LLC has 4 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Cenorin, LLC, Kent, WA.
Reason for recall
"There is a supplier quality issue with the terminal blocks which may cause the terminal block to overheat, char and/or burn."
Distribution
"Worldwide Distribution - US Nationwide in the states of CA, FL, IN, NC, NE, UT & WV; and countries of Malaysia and Taiwan"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2288-2018 | HLD Systems 600 Series Washer/Pasteurizer, UDI (01) 0085249007009 (11) 160929 (21) 61160; Model 610HT, 115V & Model 610HT, 230V Product Usage: Clean and thermally disinfect medical devices using full immersion pasteurization | 14 units | Class II | Terminated | 4 Jul 2018 |
Context
Other enforcement events for Cenorin, LLC
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 7 Jun 2017 | ThermaSure(TM), a CENORIN(TM) product, SERIES 130 MEDICAL DEVICE DRYER: (a) Model 135; (b) Model 136 Forced air dryer fo | Device | Class II | 3 |
| 24 Apr 2014 | HLD Systems Model 610 Washer/High Level Disinfector. Maximum weight of the Model 610 when filled with water is approxima | Device | Class II | 1 |
| 24 Jan 2013 | HLD System, Model 610, Medical Device Cleaning and High Level Disinfection Washer/Pasteurizer. | Device | Class II | 1 |
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "There is a supplier quality issue with the terminal blocks which may cause the terminal block to overheat, char and/or burn."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution - US Nationwide in the states of CA, FL, IN, NC, NE, UT & WV; and countries of Malaysia and Taiwan"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 13 Sep 2019. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.