Recall Z-0986-2015 ยท LWH Counter, Sponge, Surgical
Stryker Instruments Div. of Stryker Corporation
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.
| Date | Jan 15, 2015 (initiated Jun 16, 2013) |
| Status | Terminated |
| Reason | Faulty SurgiCounter Charging Cradle can prevent the scanner from charging or downloading information after a procedure. |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 3625 |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060076 | SURGICOUNT SAFETY-SPONGE SYSTEM Surgicount Medical, Mar 14, 2006 |