Recall Z-3228-2011
Terumo Cardiovascular Systems Corp · initiated August 11, 2011
Product
Cardiovascular Custom Procedure Kits, REV.2, REV. 3 PUMP & TABLE PACK 1/4 Terumo Cardiovascular Systems, Ashland, MA 0172 Item Number: 71038-05 Terumo Cardiovascular Systems Corp. The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde now and air into the heart.
Codes / lots: Lot Numbers: ME19 MG21 MK02 MM04 MN29 MP06 NF16 NH11
Reason for recall
3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at the bond that holds the two halves
FDA-determined cause: Nonconforming Material/Component
Action taken
Terumo Cardiovascular Systems initiated contact on August 12, 2011 by phone, fax, email and Urgent: Medical Device Recall mail to all affected customers. The firm advised customers of the affected product, problem and required recall actions. Customers can remove whole customized packs that are not in urgent medical need and return packs. Or the User may opt to use a sterile LH 130 vent valve from Terumo Cardiovascular Systems. A response form was included to return back to the firm. For questions on this recall contact Terumo Customer Service at (734) 525-9580.
Details
- Recall number
- Z-3228-2011
- Initiated
- August 11, 2011
- Posted by FDA
- September 16, 2011
- Terminated
- March 20, 2012
- Product code
- MJJ – Cpb Check Valve, Retrograde Flow, In-Line
- Quantity
- 50 units
- Distribution
- Nationwide Distribution, including the states of FL and MI.
- Recalling firm
- Terumo Cardiovascular Systems Corp, Ashland, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-3222-2011 | Cardiovascular Custom Procedure Kits, REV OA PERFUSION W/4:1 CARDIOPLEGIA Item Number…3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at… | 08/11/2011Terminated |
| Z-3223-2011 | Cardiovascular Custom Procedure Kits, Rev O, REV 1, REV 1A, REV 2 X-COATED 8:1 FX PACK…3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at… | 08/11/2011Terminated |
| Z-3224-2011 | Cardiovascular Custom Procedure Kits, Rev OA FX 8:1 PACK Item Number :73315 Terumo…3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at… | 08/11/2011Terminated |
| Z-3225-2011 | Cardiovascular Custom Procedure Kits, Rev O X-Coated 8:1 CP No OXY Item Number: 73329…3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at… | 08/11/2011Terminated |
| Z-3226-2011 | Cardiovascular Custom Procedure Kits, REV.0 REV.0A, REV.1 X-Coated 4:1 CP50 FX Pack Item…3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at… | 08/11/2011Terminated |
| Z-3227-2011 | Cardiovascular Custom Procedure Kits, REV..1 X-Coated Stand Alone Adult Pack Item…3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at… | 08/11/2011Terminated |
| Z-3229-2011 | Cardiovascular Custom Procedure Kits, REV.3, REV. 5 X-COATED 8:1 CARDIOPLEGIA Item…3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at… | 08/11/2011Terminated |
| Z-3230-2011 | Cardiovascular Custom Procedure Kits, REV.OB PERFUSION W/8:1 CARDIOPLEGIA Item Number:…3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at… | 08/11/2011Terminated |
| Z-3231-2011 | Cardiovascular Custom Procedure Kits, REV.4, REV. 5 X-COATED NEONATAL PACK 3/16" Item…3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at… | 08/11/2011Terminated |
| Z-3232-2011 | Cardiovascular Custom Procedure Kits, REV.0, REV 1, REV 1A, REV. 2 XCoated 8:1 FX PACK…3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at… | 08/11/2011Terminated |
| Z-3233-2011 | Cardiovascular Custom Procedure Kits, REV.0 FX 8:1 PACK Item Number: 73329 Terumo…3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at… | 08/11/2011Terminated |
| Z-3234-2011 | Adjustable Valve Item Number: 73631 Terumo Cardiovascular Systems, Ashland, MA 01721 The…3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at… | 08/11/2011Terminated |
| Z-3235-2011 | Cardiovascular Custom Procedure Kits, REV: 2 X-COATED 3/8 X 3/8 A-V LOOP Item Number:…3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at… | 08/11/2011Terminated |
| Z-3236-2011 | Cardiovascular Custom Procedure Kits, REV: 1 X-COATED 3/8 X 1/2 A-V LOOP Item Number:…3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at… | 08/11/2011Terminated |
| Z-3237-2011 | Cardiovascular Custom Procedure Kits, REV: 5 X-COATED FPS ADULT PACK Item Number: 73325…3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at… | 08/11/2011Terminated |
| Z-3238-2011 | Cardiovascular Custom Procedure Kits, REV: 5 STANDARD PACK Item Number: 71701 Terumo…3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at… | 08/11/2011Terminated |
| Z-3239-2011 | Cardiovascular Custom Procedure Kits, REV :10. REV 13, REV17, REV 18 FX X-Coated…3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at… | 08/11/2011Terminated |
| Z-3240-2011 | Cardiovascular Custom Procedure Kits, REV :2. REV 2A, REV: 17, REV 18 X-COATED FX PACK…3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at… | 08/11/2011Terminated |
| Z-3241-2011 | Cardiovascular Custom Procedure Kits, REV :3. REV: 4, REV: 5, REV: 6, REV:7 X-Coated…3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at… | 08/11/2011Terminated |
| Z-3242-2011 | Cardiovascular Custom Procedure Kits, REV : 2, REV: 4 FX, CP50,CENT Pack Item Number:…3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at… | 08/11/2011Terminated |
| Z-3243-2011 | Cardiovascular Custom Procedure Kits, REV : 3 General Low Prime Item Number: 73563…3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at… | 08/11/2011Terminated |
| Z-3244-2011 | Cardiovascular Custom Procedure Kits, REV: 2, REV:2A, REV: 5, REV: 7 X-Coated FX…3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at… | 08/11/2011Terminated |
| Z-3245-2011 | Cardiovascular Custom Procedure Kits, REV: 0, REV: 1 REV: 4, REV: 6A, REV: 6B. REV: 6C…3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at… | 08/11/2011Terminated |
| Z-3246-2011 | Cardiovascular Custom Procedure Kits, REV: 1 REV: 1A COATED FX PK Item Number: 72985-02…3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at… | 08/11/2011Terminated |
| Z-3247-2011 | Cardiovascular Custom Procedure Kits, REV: 2A, REV: 2B X-COATED FX PK Item Number: 73191…3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at… | 08/11/2011Terminated |
| Z-3248-2011 | Cardiovascular Custom Procedure Kits, REV: 1A, REV :1 X-COATED FX PK Item Number:…3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at… | 08/11/2011Terminated |
| Z-3249-2011 | Cardiovascular Custom Procedure Kits, REV: 8 Comprensive X-COATED 8000 FX PK Item…3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at… | 08/11/2011Terminated |
| Z-3250-2011 | Cardiovascular Custom Procedure Kits, REV: 4 FX, CP50 CENT. PK Item Number: 73386 Terumo…3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at… | 08/11/2011Terminated |
| Z-3251-2011 | Cardiovascular Custom Procedure Kits, REV: 3, REV: 3A, REV:4 FX, CP50 CENT. PK Item…3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at… | 08/11/2011Terminated |
| Z-3252-2011 | Cardiovascular Custom Procedure Kits, REV: 0, REV: 2, REV:6 X-Coated FX Perfusion Pack…3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at… | 08/11/2011Terminated |