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Recall Observatory FDA recall evidence

Device product

Bayonet Forceps 7.-1/8 (181.0mm) 0.75mm Non-Insulated Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-1360K 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-1998-2012

June 01, 2012

Class II

Product summary

Firm
PSC Industries Inc
Event
Event 61958
Status
Terminated
Classification
Class II
Quantity
40 Units
Official record key
device-enforcement:Z-1998-2012

Official wording

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.

Code information: Model/part Number: 20-1360K, Lot Number: 023420,, Expiration Date: 2/28/2017.

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

  • Unknown

    reason.no_named_rule · v1.0.0

    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.