FDAFDA · Food and drugs·Recall number Z-1996-2012
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.
Published July 18, 2012 · Recall initiated: June 1, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- PSC Industries Inc
- Distributor
- Worldwide distribution: USA (nationwide) including states of: CA, CT, FL, GA, MD, MI, NC, OR, SC, and TX and countries of: Canada and Philippines.
- Lot
- Model/part Number: 20-1360I, Lot Number: 023399, Expiration Date: 02/28/2017.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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