Z-0138-04

IntelliSystem25 Inflation Device and Fluid Dispensing Syringe - Label on package reads in part...

Name: Z-0138-04 IntelliSystem25 Inflation Device and Fluid Dispensing Syringe - Label on package reads in part...
Creator: Merit Medical Systems, Inc
Published: 2003-10-01
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2003-10-01 / Terminated / root cause: packaging

FDA source

Merit Medical Systems, Inc began a recall of IntelliSystem25 Inflation Device and Fluid Dispensing Syringe - Label on package reads in part: ''INTELLISYSTEM 25 WITH MAP152 MAP152 CONTAINS: MERIT ACCESS... on 2003-10-01. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0138-04
Status: Terminated
Initiated: 2003-10-01
Posted: 2003-11-19
Terminated: 2004-02-02
Recalling firm: Merit Medical Systems, Inc.
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
Product code: DXT Injector And Syringe, Angiographic
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.
Root cause tag: packaging
FDA root cause: Other
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.
Quantity in commerce: 626 units
Distribution: Distributed nationwide. International distribution includes Canada, Japan, Korea, England and France.
Product codes and lots: Lot # A285003.

Product code DXT

K884913Class IIMerit Intelliflator(tm) & Merit Monitor(tm)Merit Medical Systems, Inc. / cleared 1989-04-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)