Recall Z-1995-2012 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
PSC Industries Inc
Bayonet Forceps 8.5" (215.9mm) Serrated 1.0 mm Tips Electrosurgical/Monopolar Forceps/Reusable, Model #41604, 510 (k) #K885199. The surgical device is package in non-sterile small plastic tubes. Monopolar Reusable Forceps - are intended for use in cutting and coagulating tissue during surgical procedures.
| Date | Jul 12, 2012 (initiated Jun 1, 2012) |
| Status | Terminated |
| Reason | Firm officials reported to CIN-DO that their Electrosurgical Monopolar Reusable Bayonet Forceps are misbranded in that the label states that the tip size is: (0.5mm) when the tip size actually measures (1.0mm). |
| Root cause | Labeling mix-ups |
| Action | The firm, Olsen Medical, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated June 5, 2012 to their customers via Certified mail along with representative labeling to illustrate the specific labeling issue associated with the various types and/or sizes of Bayonet Forceps surgical instruments that the customers received. The letter described the product, problem and actions to be taken. The letter instructed the customers to immediately examine their inventory for the presence of the suspect product and quarantine the product, if found; to discontinue use immediately and promptly call (800) 251 |
| Quantity | 5 units |
| Distribution | Worldwide distribution: USA (nationwide) including states of: CA, CT, FL, GA, MD, MI, NC, OR, SC, and TX and countries of: Canada and Philippines. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982705 | MIDAS TOUCH BIPOLAR FORCEPS Iti Medical Technologies, Inc., Sep 8, 1998 |