Sydney IVF Culture Oil, REF, K- SICO- 50, 50 mL. and K-SICO-200, 200 mL,Store at 2-8 C, Sterile, Cook Medical, William A
FDA device recall Z-1324-2012 · posted 2012-03-28 · Terminated
Recall details
- Recalling firm
- Cook, Inc.
- Reason for recall
- Cook Medical is recalling Sydney IVF Culture Oil due to a number of recent customer complaints that have identified it as a possible cause of embryo degeneration at day 5/6.
- Action taken
- Cook Medical sent an Urgent Recall Notices letter dated February 15, 2012 to all affected customers. The letter identified the recall product, reason for the recall and actions to be taken. The notice included directions to pull the recalled product from stock, isolate it and forward the notice to any sub-accounts. Customers were requested to complete and return the recall acknowlegement and product tracking form by to Fax: 812-829-1801 or Email: julie.cooper@cookmedical.com. For questions call 800-457-4448 x7241.
- Root cause
- Process control
- Status
- Terminated
- Product code
- MQL
- Quantity affected
- 54 total from both lots
- Distribution
- Worldwide Distribution - USA (nationwide) including the states of IL, KS, KY, MA, NJ. TN, TX, UT, VA, WI, WV, and the country of Barbados.
- Date initiated
- 2012-02-15
- Date posted
- 2012-03-28
- Date terminated
- 2012-07-03
- Location
- Bloomington, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYDNEY IVF CULTURE OIL (K022002) | Cook Urological, Inc. | 2002-08-12 |