Central Venous Catheter Tray, Double Lumen Polyurethane 5.0 Fr/ 12 cm, C-UDLMY-501J- RSC-CHILDRENS-HCT, G44041, Sterile,
FDA device recall Z-1137-2011 · posted 2011-02-23 · Terminated
Recall details
- Recalling firm
- Cook, Inc.
- Reason for recall
- Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection USP 5 mL fill in 6 mL flush syringes that have been recalled by Excelsior Medical. During a routine test for syringe sterility, a possible integrity failure wa
- Action taken
- Cook, Inc. sent URGENT DEVICE RECALLS letters to its customers dated 10/4/2010. The letters asked customers to examine their inventory and notify Cook for product return. The letter included a response form.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- FOZ
- Quantity affected
- 51,473 total kits/trays
- Distribution
- Worldwide distribution: USA, Chile, Colombia, Panama, Barbados, Canada, Guatemala, and Saudi Arabia.
- Date initiated
- 2010-10-04
- Date posted
- 2011-02-23
- Date terminated
- 2011-06-21
- 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 |
|---|---|---|
| COOK AND COOK SPECTRUM CENTRAL VENOUS CATHETERS (K081113) | Cook, Inc. | 2008-07-30 |