Recall Z-1997-2012— PSC Industries Inc

Name: FDA recall Z-1997-2012
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 8.25 (209.6 mm) 0.5mm Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-13420, 510 (k) #K884175. The surgical device is package one (1) per Tyvek peel pouch with ten (10) Tyvek peel pouches per box. Bipolar Forceps and Cords - Olsen Medical Bipolar Forceps and Cords are intended for use in coagulating tissue during surgical procedures. Reason: Firm officials reported to CIN-DO that for this device, in the labeling on the inner Tyvek peel pouch, the letter 'E' in Electrosurgical was turned into an 'X' and the number '5" of the (mm tips) was turned into a '0'. This affected the description and some of the text of the labels. However, it did not t affect the Part Number and Lot Number on the label..

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 8.25 (209.6 mm) 0.5mm Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-13420, 510 (k) #K884175. The surgical device is package one (1) per Tyvek peel pouch with ten (10) Tyvek peel pouches per box. Bipolar Forceps and Cords - Olsen Medical Bipolar Forceps and Cords are intended for use in coagulating tissue during surgical procedures

Reason for recall

Firm officials reported to CIN-DO that for this device, in the labeling on the inner Tyvek peel pouch, the letter 'E' in Electrosurgical was turned into an 'X' and the number '5" of the (mm tips) was turned into a '0'. This affected the description and some of the text of the labels. However, it did not t affect the Part Number and Lot Number on the label.

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