Vital Signs Disposable General Purpose 9 French Temperature Probe For monitoring of core temperature
FDA device recall Z-0407-2013 · posted 2012-11-20 · Terminated
Recall details
- Recalling firm
- Vital Signs Colorado Inc.
- Reason for recall
- There is a potential for epistaxis during use of the Disposable General Purpose 9 French Temperature Probe.
- Action taken
- The firm,GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter and Confirmation form on August 17, 2012 via Fed Ex to its consignees/customers. The letter describes the product, problem and action to be taken. The customers were instructed to do the following: Do not use the Disposable General Purpose 9 French Temperature Probe P/N 1016 or 1016EU; return all unopened product(s) to Vital Signs Devices (VSD) 11039 East Lansing Circle, Englewood, CO 80112-note: replacements and/or refunds discussed in letter are available only in exchange for the return of any unopened product(s); complete and return the URGENT MEDICAL DEVICE CORRECTION CONFIRMATION via fax to: 800-535-7923; forward a copy of the letter to any institutions they may have forwarded the product and for customers using the GXXXXX64 kit that includes the Disposable General Purpose 9 French Temperature Probe follow the directions listed in the letter. Note: VSD is removing p/n 1016 and 1016EU, Disposable General Purpose 9 French Temperature Probe, from the market and offering a replacement. If you have any questions or concerns regarding this notification, contact Customer Service at +1-800-932-0760 (Domestic & International). Hours of Operation 8:00 am EST to 6:00 pm EST.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- KAK
- Quantity affected
- 243,685 units
- Distribution
- Worldwide distribution: USA (nationwide) including states of: AR, CA, FL,GA, IL, LA, MA, MI, MO, NC, NH, NY, OH, OK, PA, RI, SE,TX, and WA; and countries of: AUSTRALIA, BARCELONA, GERMANY, NEW ZEALAND
- Date initiated
- 2012-08-17
- Date posted
- 2012-11-20
- Date terminated
- 2013-06-14
- Location
- Englewood, CO
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GENERAL ANESTHESIA SYSTEM (K944949) | Vital Signs, Inc. | 1994-11-14 |
| EXAC-TEMP & CLINI-TEMP PROBE W/TEMPERATURE SENSOR (K925791) | Deroyal Industries, Inc. | 1994-02-25 |
| ROSEN'S STAPES NEEDLE EXPLORER (K822277) | Kelleher Corp. | 1982-08-25 |