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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Model/part Number: 20-1360K, Lot Number: 023420,, Expiration Date: 2/28/2017.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- PSC Industries Inc
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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.
Product Codes/Lot Numbers:
Model/part Number: 20-1360K, Lot Number: 023420,, Expiration Date: 2/28/2017.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1998-2012
Related Recalls
Firm officials reported to CIN-DO that their Bipolar Bayonet Forceps 7.75" are misbranded in that the manufacturer symbol was replaced by the expiry symbol on the packaging.
The carton label for this device has the manufacturer symbol where the expiration date symbol should be. Firm officials met with FDA on 5/17/2012. At which time, they reported various labeling errors for their Button Switch Pen Electrode Electrosurgical /Extendable Pencils.
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.