Recall Z-2748-2015 ยท LZG Pump, Infusion, Insulin
Elcam Medical, Inc.
Elcam Medical Minimal Residual Volume Luer activated Swabbable stopcock (MRVLS) for pressure monitoring and intravenous fluid administration; Manufactured by: Elcam Medical ACAL, Israel. Sterile, Quantity 20.
| Date | Sep 10, 2015 (initiated Jul 19, 2015) |
| Status | Terminated |
| Reason | Punctured blister packages were detected during the packaging process at the manufacturing site. Potential for device contamination. |
| Root cause | Packaging |
| Action | Elcam Medical sent "Urgent: Stopcock Recall" notices and "Recall Return Response Forms" dated 7/19/2015 to their customers. The recall notification informed the customers of the reason for the recall and the actions they must take. Customers were instructed to cease distribution and quarantine any affected products; return to Elcam Medical the enclosed Recall Return Response Form; and notify their customers as per their recall procedures. |
| Quantity | 7,721,580 units |
| Distribution | Texas, New Mexico and Pennsylvania |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122953 | OMNIPOD INSULIN MANAGMENT SYSTEM Insulet Corporation, Dec 7, 2012 |