Recall Z-1996-2012— PSC Industries Inc

Name: FDA recall Z-1996-2012
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: K884656. Product: Bayonet Forceps 7.-1/8 (181.0mm) 0.75mm Insulated Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-1360I, 510 (k) #K884656. The surgical device is package one (s) per plastic Tyvek peel pouch, 10 plastic 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 the outer carton label of this sterile, single use device is misbranded in that it lists an incorrect expiration date. The outer carton label lists the sterile expiration date as: 2012-02-(28) [the manufacture date] ; however the device pouch label lists the sterile date as: 2017-02-(28). The pouch label lists the correct sterile expiration date..

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

K884656 — DISPOSABLE BIPOLAR CORD AND BIPOLAR FORCEPDermacare·cleared 1988-11-25

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.-1/8 (181.0mm) 0.75mm Insulated Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-1360I, 510 (k) #K884656. The surgical device is package one (s) per plastic Tyvek peel pouch, 10 plastic 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 the outer carton label of this sterile, single use device is misbranded in that it lists an incorrect expiration date. The outer carton label lists the sterile expiration date as: 2012-02-(28) [the manufacture date] ; however the device pouch label lists the sterile date as: 2017-02-(28). The pouch label lists the correct sterile expiration date.

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