Pressure Monitoring Tubing, PM6006. Pressure Monitoring Tubing (PM series) is used between the manifold and transducer a
FDA device recall Z-1319-2014 · posted 2014-04-03 · Terminated
Recall details
- Recalling firm
- Merit Medical Systems, Inc.
- Reason for recall
- The products are labeled as sterile but were not sterilized.
- Action taken
- Merit Medical sent an Urgent Product Recall Notice dated March 14, 2014 to all customers and sales representatives via email. The letter identified the affected product, problem and actions to be taken. Customers were provided a Product Retrieval Form, product identification information, instruction to immediately quarantine any devices and discontinue use, ensure all personnel to whom devices were distributed are made aware of this field action, and instructions to contact their Merit representative to arrange product return and replacement. For questions call 1-801-316-4822.
- Root cause
- Release of Material/Component prior to receiving test results
- Status
- Terminated
- Product code
- OBI
- Quantity affected
- 80
- Distribution
- Worldwide Distribution - USA Nationwide in the state of WI and countries of Thailand and Hong Kong.
- Date initiated
- 2014-03-13
- Date posted
- 2014-04-03
- Date terminated
- 2014-07-07
- Location
- South Jordan, UT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MERIT HI-FLEX(TM) (K883718) | Merit Medical Systems, Inc. | 1989-01-30 |