VacLok Syringe. Label reads in part: ''VACLOC SYRINGE 60 ml VACLOF SYRINGE-FIXED MALE LUER ... MERIT MEDICAL''. Sterile if package is unopened or undamaged. Part #VAC160.
This recall has been terminated (originally issued November 19, 2003).
- Company
- Merit Medical Systems, Inc
- Recall Initiated
- October 1, 2003
- Posted
- November 19, 2003
- Terminated
- February 2, 2004
- Recall Number
- Z-0139-04
- Quantity
- 287 units
- Firm Location
- Jordan, UT
- Official Source
- View on FDA website ↗
Reason for Recall
There is a potential for the PETG blister trays to bond together with varying degrees of attachment. The potential for non-sterility exists when the attached trays are seperated by force and holes or cracks are generated in the seperated trays.
Distribution
Distributed nationwide. International distribution includes Canada, Japan, Korea, England and France.
Lot / Code Info
Lot # A282003
Root Cause
Other
Action Taken
Merit notified sales representatives, domestic and international accounts and dealers immediately by letter dated October 3, 2003. The manufacturer requests that the use of the affected inventory should immediately cease and that on-hand units should be promptly isolated from general inventory for simultaneous inspection by a site representative and a Merit sales representative.