—#30008

Product

IntelliSystem25 Inflation Device and Fluid Dispensing Syringe - Label on package reads in part: ''INTELLISYSTEM 25 WITH MAP152 MAP152 CONTAINS: MERIT ACCESS PLUS LARGE BORE HEMOSTASIS VALVE, TORGUE DEVICE AND METAL GUIDE WIRE INSERTION TOOL...MERIT MEDICAL'', Latex free. Sterile if package is unopened or undamaged. Part # 1525/B

FDA product code: DXT — Injector And Syringe, Angiographic
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K884913
Affected lot / code info: Lot # A285003.

Why it was recalled

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.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Merit Medical Systems, Inc
Address: 1600 Merit Pkwy South, Jordan, Utah 84095-2416

Distribution

Distribution pattern: Distributed nationwide. International distribution includes Canada, Japan, Korea, England and France.

Timeline

Recall initiated: 2003-10-01
Posted by FDA: 2003-11-19
Terminated: 2004-02-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #30008. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.