IntelliSystem25 Inflation Device and Fluid Dispensing Syringe - Label on package reads in part: ''INTELLISYSTEM 25 WITH
FDA device recall Z-0138-04 · posted 2003-11-19 · Terminated
Recall details
- Recalling firm
- Merit Medical Systems, Inc
- 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.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- DXT
- Quantity affected
- 626 units
- Distribution
- Distributed nationwide. International distribution includes Canada, Japan, Korea, England and France.
- Date initiated
- 2003-10-01
- Date posted
- 2003-11-19
- Date terminated
- 2004-02-02
- Location
- South Jordan, UT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MERIT INTELLIFLATOR(TM) & MERIT MONITOR(TM) (K884913) | Merit Medical Systems, Inc. | 1989-04-18 |