Recall Z-1994-2012— PSC Industries Inc

Name: FDA recall Z-1994-2012
Creator: U.S. Food and Drug Administration
Published: 2012-06-01

Class II · Terminated

Class II FDA medical device recall by PSC Industries Inc, initiated 2012-06-01, terminated 2015-09-15. It names one FDA 510(k) clearance: K885199. Product: Bayonet Forceps 7.75" (196.9 mm) 0.5 mm Tips Non-Stick Electrosurgical/Bipolar Forceps/Reusable, Model #90-7004 (k) #K982705. The surgical device is package non-sterile into small plastic tubes. Olsen Medical Biopolar Reusable Bayonet Forceps and cords are intended for use in coagulating tissue during surgical procedures.. Reason: Firm officials reported to CIN-DO that their Bipolar Bayonet Forceps 7.75" are misbranded in that the manufacturer symbol was replaced by the expiry symbol on the packaging..

Recalling firm: PSC Industries Inc
Classification: Class II
Status: Terminated
Initiated: 2012-06-01
Terminated: 2015-09-15
Firm location: Louisville, KY, United States

510(k) clearances named in this recall

1 on FDA's record

K885199 — #500 SERIES FORCEPS W/CUT/COAGULATE SWITCHESOlsen Electrosurgical, Inc.·cleared 1989-01-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Bayonet Forceps 7.75" (196.9 mm) 0.5 mm Tips Non-Stick Electrosurgical/Bipolar Forceps/Reusable, Model #90-7004 (k) #K982705. The surgical device is package non-sterile into small plastic tubes. Olsen Medical Biopolar Reusable Bayonet Forceps and cords are intended for use in coagulating tissue during surgical procedures.

Reason for recall

Firm officials reported to CIN-DO that their Bipolar Bayonet Forceps 7.75" are misbranded in that the manufacturer symbol was replaced by the expiry symbol on the packaging.

Data sourced from openFDA. This site is unofficial and independent of the FDA.