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Recall Observatory FDA recall evidence

Device 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.

Z-1996-2012

June 01, 2012

Class II

Product summary

Firm
PSC Industries Inc
Event
Event 61958
Status
Terminated
Classification
Class II
Quantity
80 units
Official record key
device-enforcement:Z-1996-2012

Official wording

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.

Code information: Model/part Number: 20-1360I, Lot Number: 023399, Expiration Date: 02/28/2017.

Distribution pattern: Worldwide distribution: USA (nationwide) including states of: CA, CT, FL, GA, MD, MI, NC, OR, SC, and TX and countries of: Canada and Philippines.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    misbranded