Elcam Medical Minimal Residual Volume Luer activated Swabbable stopcock (MRVLS) for pressure monitoring and intravenous
FDA device recall Z-2748-2015 · posted 2015-09-10 · Terminated
Recall details
- Recalling firm
- Elcam Medical, Inc.
- Reason for recall
- Punctured blister packages were detected during the packaging process at the manufacturing site. Potential for device contamination.
- Action taken
- 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.
- Root cause
- Packaging
- Status
- Terminated
- Product code
- LZG
- Quantity affected
- 7,721,580 units
- Distribution
- Texas, New Mexico and Pennsylvania
- Date initiated
- 2015-07-19
- Date posted
- 2015-09-10
- Date terminated
- 2017-09-18
- Location
- Hackensack, NJ
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