Food, drugs, devices › Terumo Cardiovascular Systems Corp
Device recall: Terumo Custom Cardiovascular Procedure Kit Tubing Pack P/N: 66041-1 Terumo Cardiovascular Procedure Kits are manufacture
FDA enforcement event 72010 is a device recall by Terumo Cardiovascular Systems Corp of Ashland, MA, initiated 24 Aug 2015 and classified Class II, with 7 product records.
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. 91% of the 1,153 device enforcement events initiated in 2015 carry the same class.
Status: Terminated, terminated 5 Feb 2016. Initiation: voluntary: firm initiated. Terumo Cardiovascular Systems Corp has 8 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
Terumo Cardiovascular Systems Corp, Ashland, MA.
Reason for recall
"Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performance Hemoconcentrators"
Distribution
"Nationwide Distribution including CA, CT , FL , WI."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2786-2015 | Terumo Custom Cardiovascular Procedure Kit Tubing Pack P/N: 66041-1 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the application intended by the end user. The kits are comprised of a… | 5 kits | Class II | Terminated | 30 Sep 2015 |
| Z-2787-2015 | Terumo Custom Cardiovascular Procedure Kit X-Coated Adult Pak P/N: 73124 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the application intended by the end user. The kits are comprised… | 32 kits | Class II | Terminated | 30 Sep 2015 |
| Z-2788-2015 | Terumo Custom Cardiovascular Procedure Kit X-Coated Perfusion Pack with FX25RE P/N: 7928-03 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the application intended by the end user. The… | 30 kits | Class II | Terminated | 30 Sep 2015 |
| Z-2789-2015 | Terumo Custom Cardiovascular Procedure Kit X-Coated Pediatric Pack P/N: 74039-02 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the application intended by the end user. The kits are… | 6 kits | Class II | Terminated | 30 Sep 2015 |
| Z-2790-2015 | Terumo Custom Cardiovascular Procedure Kit X-Coated Perfusion Pack P/N: 74077-01 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the application intended by the end user. The kits are… | 15 kits | Class II | Terminated | 30 Sep 2015 |
| Z-2791-2015 | Terumo Custom Cardiovascular Procedure Kit X-Coated PED/Adult Main Pack P/N: 75185 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the application intended by the end user. The kits are… | 19 kits | Class II | Terminated | 30 Sep 2015 |
| Z-2792-2015 | Terumo Custom Cardiovascular Procedure Kit X-Coated PED/Adult Main Pack P/N: 75529 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the application intended by the end user. The kits are… | 17 kits | Class II | Terminated | 30 Sep 2015 |
Context
Other enforcement events for Terumo Cardiovascular Systems Corp
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 3 Feb 2022 | Cardiovascular Procedure Kit catalog # 76645 & 73806 | Device | Class II | 1 |
| 18 Dec 2017 | Terumo Cardiovascular Procedure Kits containing Pall LG6NS LeukoGuard¿ Leukocyte Reduction Arterial Blood Filters. The C | Device | Class II | 1 |
| 12 May 2017 | Tubing Pack Convenience Kit, Product Code 65217 Product Usage: Intended for use only in the extracorporeal circuit of th | Device | Class II | 1 |
| 25 Jul 2016 | Terumo Custom Cardiovascular System Cardiovascular Procedure Kits labeled containing Coated Tubing as follows: This prod | Device | Class II | 1 |
| 6 May 2015 | Custom Cardiovascular Procedure Kits; Over-Pressure Safety Valves. For use only in the extracorporeal circuit for the ca | Device | Class II | 1 |
| 28 Mar 2014 | Terumo Cardiovascular Procedure Kit- X-Coated Pump and Table Pack with FX25RE Catalog Number: 73431 | Device | Class II | 1 |
| 1 Mar 2011 | Terumo Custom Cardioplegia Delivery Set - Heat Exchanger Cardiopulmonary Bypass Item Numbers: 5852, 16010 Product Usage: | Device | Class II | 6 |
All 8 events for Terumo Cardiovascular Systems Corp
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performance Hemoconcentrators"
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: "Nationwide Distribution including CA, CT , FL , WI."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 5 Feb 2016. "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.