Recall Z-2154-2010
Terumo Cardiovascular Systems Corp · initiated June 8, 2010
Product
Terumo Cardiovascular Procedure Kit Custom ADULT PACK P/N 71546-01
Codes / lots: Lots: MF03
Reason for recall
Vent port may be occluded and prevent delivery of fluid
FDA-determined cause: Equipment maintenance
Action taken
Terumo, Ashland, MA notified consignees on 6/8/10, by phone, fax, email and mail to advise distributors and end-users of the required recall actions. Follow-up communication sent by priority overnight mail on 6/9/10, with proof of delivery, specifying the awareness to the issue and necessary correction activities should a unit be discovered. Phase 2 initiated on 7/1/10 to sale rep to remove recalled product and perform a product reconciliation to ensure that all affected product is identified, returned to Terumo CVS, and that replacement product is sent immediately.
Details
- Recall number
- Z-2154-2010
- Initiated
- June 8, 2010
- Posted by FDA
- August 2, 2010
- Terminated
- May 7, 2012
- Product code
- DTR – Heat-Exchanger, Cardiopulmonary Bypass
- Quantity
- 4 packs
- Distribution
- Distribution USA and Canada
- Recalling firm
- Terumo Cardiovascular Systems Corp, Ashland, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2149-2010 | Terumo Cardiovascular Procedure Kit Custom Open Perfusion Pack P/N 64937Vent port may be occluded and prevent delivery of fluid | 06/08/2010Terminated |
| Z-2150-2010 | Terumo Cardiovascular Procedure Kit Custom 1:1 CONDUCER/MP4 CRYSTALLOID CARDIOPLEGIA P/N…Vent port may be occluded and prevent delivery of fluid | 06/08/2010Terminated |
| Z-2151-2010 | Terumo Cardiovascular Procedure Kit Custom MP4, 4:1, PRELIEF, W/RECIRC, COND / PUMP &…Vent port may be occluded and prevent delivery of fluid | 06/08/2010Terminated |
| Z-2152-2010 | Terumo Cardiovascular Procedure Kit Custom 8:1 CARDIOPLEGIA SET P/N 70608-01Vent port may be occluded and prevent delivery of fluid | 06/08/2010Terminated |
| Z-2153-2010 | Terumo Cardiovascular Procedure Kit Custom X-COATED ADULT PRESTIGE PACK P/N 71544-01Vent port may be occluded and prevent delivery of fluid | 06/08/2010Terminated |
| Z-2155-2010 | Terumo Cardiovascular Procedure Kit Custom PERFUSION TUBING PACK P/N 71733Vent port may be occluded and prevent delivery of fluid | 06/08/2010Terminated |
| Z-2156-2010 | Terumo Cardiovascular Procedure Kit Custom X-COATED HEART/LUNG FRAMEPACK P/N 71766PPVent port may be occluded and prevent delivery of fluid | 06/08/2010Terminated |
| Z-2157-2010 | Terumo Cardiovascular Procedure Kit Custom X-COATED PERFUSION PACK P/N 71934Vent port may be occluded and prevent delivery of fluid | 06/08/2010Terminated |
| Z-2158-2010 | Terumo Cardiovascular Procedure Kit Custom X-COATED PUMP AND TABLE PACK W/8:1…Vent port may be occluded and prevent delivery of fluid | 06/08/2010Terminated |
| Z-2159-2010 | Terumo Cardiovascular Procedure Kit Custom X-COATED MASTER PACK P/N 72790Vent port may be occluded and prevent delivery of fluid | 06/08/2010Terminated |
| Z-2160-2010 | Terumo Cardiovascular Procedure Kit Custom X-COATED ADULT PACK P/N 72846Vent port may be occluded and prevent delivery of fluid | 06/08/2010Terminated |
| Z-2161-2010 | Terumo Cardiovascular Procedure Kit Custom ADULT PACK P/N: 131351-02Vent port may be occluded and prevent delivery of fluid | 06/08/2010Terminated |
| Z-2162-2010 | Terumo Cardiovascular Procedure Kit Custom X-COATED HEART - LUNG PACK P/N: 70608-01Vent port may be occluded and prevent delivery of fluid | 06/08/2010Terminated |
| Z-2163-2010 | Terumo Cardiovascular Procedure Kit Custom CONDUCER/MP4 8:1 NO RECIRC. DOUBLE SPIKE P/N:…Vent port may be occluded and prevent delivery of fluid | 06/08/2010Terminated |