Smart Perfusion Pack, REF: 088501900, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004 Indicated f
FDA device recall Z-1097-2010 · posted 2010-03-12 · Terminated
Recall details
- Recalling firm
- Sorin Group USA, Inc.
- Reason for recall
- Tubing set packaging seal between lid and tray may not be adequately sealed, compromosing sterility.
- Action taken
- Customers were notified by letter on December 30, 2009 and asked to examine all inventory for seal voids and arrange for return if any were found defective. Examination instructions were included. The two distributors were given the same instructions and were told to share all the information with any of their customers.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- DWF
- Quantity affected
- 9 units
- Distribution
- AZ, CA, FL, MO, NJ, SC, SD, TN, TX, UT, VA and WI.
- Date initiated
- 2009-12-30
- Date posted
- 2010-03-12
- Date terminated
- 2010-03-15
- Location
- Arvada, CO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| COBE HEART/LUNG PERFUSION AND CARDIOPLEGIA PACK (K881330) | Cobe Laboratories, Inc. | 1988-06-10 |