Recall Z-1175-06 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Gyrus Medical, Inc.
GYRUS ACMI PKS PlasmaSEAL Open Forceps, model 2103PK and 917015PK. Sterile EO. The device is intended to be used with the PlasmaKinetic electrosurgical generator, software version 1.93 or greater or the PlasmaKinetic with SuperPulse electrosurgical generator, software version 2.19A or greater or the G400 electrosurgical generator. Made in USA Gyrus ACMI, Gyrus Medical, Inc., 6655 Wedgwood Road,
| Date | Jun 27, 2006 (initiated May 15, 2006) |
| Status | Terminated |
| Reason | Gyrus ACMI has identified a product issue wherein their PlasmaSEAL Open Forceps, models 2103PK and 917015PK, may not deliver adequate hemostasis during use. Although Gyrus ACMI has had no reports of serious injury to patient, testing indicated that the possibility exists. |
| Root cause | Other |
| Action | US accounts were initially contacted by phone beginning 05/15/2006 and then sent a follow-up letter sent 05/31/2006. Customers were told of the issue, instructed to discontinue use of the product, told to remove all 2103PK and 917015PK devices from shelves and to quarantine product until they receive a letter with instructions to return the affected devices to Gyrus ACMI. |
| Quantity | 2971 (2931 domestic, 40 OUS) |
| Distribution | Nationwide, Australia, Canada, Netherlands. (AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SC, TN, TX, VA, WA, WI, WV). |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020585 | ZIP OPEN FORCEPS WITH ELECTROSURGICAL CUT Gyrus Medical, Inc., Jul 13, 2002 |