Level 1 Normothermic I.V. Fluid Administration Sets, Product Code D-60HL , Product Usage: Single patient use sets design
FDA device recall Z-0427-2012 · posted 2012-01-11 · Terminated
Recall details
- Recalling firm
- Smiths Medical ASD, Inc.
- Reason for recall
- Disconnected/ loose Luer connectors at the patient end of the triple lumen tubing of the HOTLlNE Disposable Administration Sets and Level 1 D/DI-60HL Normothermic IV Administration Sets
- Action taken
- Smiths Medical notified consignees by letter dated November 28, 2011 titled: Urgent Field Safety Notice. The letter identified the affected product, the problem, and the actions to be taken. Customers were instructed to inspect inventory and segregate unused affected product. Distributors were instructed to immediately stop distributing and quarantine all inventory. The letters included a Confirmation Form to be complete and return, by fax to 781-610-9859 or by email to hotlineconnectorrecall@smiths-medical.com. For questions consignees were instructed to contact Smiths Medical at 1781-763-9330.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- LGZ
- Quantity affected
- 3062 units
- Distribution
- Worldwide Distribution (USA) (nationwide) - Argentina, Austria, Australia, Belgium, Bahrain, Bermuda, Canada, Chile, China, Columbia, Czech Republic, Germany, Denmark, Estonia, Egypt, Finland, France,
- Date initiated
- 2011-11-21
- Date posted
- 2012-01-11
- Date terminated
- 2014-08-07
- Location
- Rockland, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HOTLINE FLUID WARMER (K911383) | Level 1 Technologies, Inc. | 1991-10-17 |