Recall Z-1222-06 ยท DWE Tubing, Pump, Cardiopulmonary Bypass
International Biophysics Corp
IBC Suction Handle (Sterile), a component of Blood Recovery Suction Systems, part #1990S; International Biophysics Corp., Austin, TX.
| Date | Jul 12, 2006 (initiated Aug 16, 2005) |
| Status | Terminated |
| Reason | Tyvek pouches containing device labeled as sterile have defective seals. |
| Root cause | Other |
| Action | Firm notified customer via telephone on 08/16/05. |
| Quantity | 179 units. |
| Distribution | Product distributed to one hospital located in FL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K841959 | CARDIO METRIC CUSTOM PERFUSION TUBING Sterile Design, Inc., Oct 19, 1984 |