IBC Suction Handle (Sterile), a component of Blood Recovery Suction Systems, part #1990S; International Biophysics Corp.
FDA device recall Z-1222-06 · posted 2006-07-12 · Terminated
Recall details
- Recalling firm
- International Biophysics Corp
- Reason for recall
- Tyvek pouches containing device labeled as sterile have defective seals.
- Action taken
- Firm notified customer via telephone on 08/16/05.
- Root cause
- Other
- Status
- Terminated
- Product code
- DWE
- Quantity affected
- 179 units.
- Distribution
- Product distributed to one hospital located in FL.
- Date initiated
- 2005-08-16
- Date posted
- 2006-07-12
- Date terminated
- 2006-07-17
- Location
- Austin, TX
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CARDIO METRIC CUSTOM PERFUSION TUBING (K841959) | Sterile Design, Inc. | 1984-10-19 |