Recalls / —
—#132241
Product
The SurgiCounter Charging Cradle Product Usage: SurgiCounter Charging Cradles are designed to be used with the SurgiCounter and are part of the SurgiCount Safety-Sponge System. The SurgiCount Safety-Sponge System is indicated for use in counting and recording the number of Safety-Sponge surgical sponges, laparotomy sponges, and towels used during surgical procedures.
- FDA product code
- LWH — Counter, Sponge, Surgical
- Device class
- Class 1
- Medical specialty
- General Hospital
- 510(k) numbers
- K060076
- Affected lot / code info
- Part number: SC-0014 All lots at time of notice 6/16/2013
Why it was recalled
Faulty SurgiCounter Charging Cradle can prevent the scanner from charging or downloading information after a procedure.
Root cause (FDA determination)
Device Design
Action the firm took
On 6/16/2013, Improvements to the SurgiCounter" charging base notifications were emailed to the affected users with instructions for requesting a replacement product. The notification included a description of the reason for the recall, affected product, and instructions for responding to the notification. For questions, call the Support team any time at (877) 520-2300 option 1, or support@scmd.com.
Recalling firm
- Firm
- Stryker Instruments Div. of Stryker Corporation
- Address
- 4100 E Milham Ave, Portage, Michigan 49002-9704
Distribution
- Distribution pattern
- US Nationwide Distribution in the states of AK, AL, AR, AZ, CA, CT, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY.
Timeline
- Recall initiated
- 2013-06-16
- Posted by FDA
- 2015-01-15
- Terminated
- 2015-08-20
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #132241. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.