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Terminated

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 Recall Z-0138-04 · Posted 2003-11-19

Recalling FirmMerit Medical Systems, Inc
Recall StatusTerminated
Product CodeDXT
Date Initiated2003-10-01
Date Terminated2004-02-02
Product Quantity626 units

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.

Firm Action

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.

Root Cause

Other

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K884913MERIT INTELLIFLATOR(TM) & MERIT MONITOR(TM)Merit Medical Systems, Inc. · 1989-04-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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