Hemotherm Dual Reservoir Cooler/Heater System Models 400CE and 400MR Product Usage: A dual reservoir, water re-circulati
FDA device recall Z-0629-2018 · posted 2018-02-13 · Terminated
Recall details
- Recalling firm
- Cincinnati Sub-Zero Products LLC
- Reason for recall
- Due to FDA's safety communication relating to nontuberculous mycobacteria (NTM) infections related to heater/cooler devices, an updated Instructions For Use includes a more robust cleaning & disinfection procedure.
- Action taken
- Between November 27, 2017 - December 8, 2017, Cincinnati Sub-Zero Products LLC, distributed Urgent Medical Device Correction notices to their customers via Email and USPS. This Medical Device Correction has been initiated to provide a labeling update to the cleaning & disinfection procedures. The update addresses the disinfection process, cleaning of reusable accessories, as well as clarifying the water type that should be used with the Hemotherm. Customers are encouraged to do the following: 1) Discard your current Hemotherm Operation & Technical Manual and/or Operation Manual. 2) Replace your current Hemotherm Operation & Technical Manual and/or Operation Manual with the enclosed updated Manual(s). For your convenience, all updates have been highlighted in the manuals. " For Hemotherm 400CE users, utilize the P/N 56418-R Operation & Technical Manual and P/N 56075-G Operation Manuals. " For Hemotherm 400MR users, utilize the P/N 56234-S Operation Manual. All customers are encouraged to complete and return the enclosed response form by fax or email to FA2016-009@genthermcsz.com; Fax: 513-772-9119. Customers with questions or concerns, please contact the Field Action Coordinator: Kathy DeSmidt, E-mail: FA2016-009@genthermcsz.com, Phone: 513-772-8810 or 800-989-7373.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- DWC
- Quantity affected
- 1355 units
- Distribution
- US Nationwide Distribution
- Date initiated
- 2017-11-27
- Date posted
- 2018-02-13
- Date terminated
- 2018-07-02
- Location
- Cincinnati, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM (K122813) | Cincinnati Sub-Zero Products, Inc. | 2012-12-18 |