Bayonet Forceps 7.-1/8 (181.0mm) 0.75mm Non-Insulated Tips, Sterile Single Use Surgical/Bipolar F...
FDA Device Recall #Z-1998-2012 — Class II — June 1, 2012
Recall Summary
| Recall Number | Z-1998-2012 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 1, 2012 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | PSC Industries Inc |
| Location | Louisville, KY |
| Product Type | Devices |
| Quantity | 40 Units |
Product 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.
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.
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.
Lot / Code Information
Model/part Number: 20-1360K, Lot Number: 023420,, Expiration Date: 2/28/2017.
Other Recalls from PSC Industries Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1990-2012 | Class II | Button Switchpens, w/Extendable Needle Electrod... | Jun 5, 2012 |
| Z-1991-2012 | Class II | Button Switchpens, w/Extendable Needle Electrod... | Jun 5, 2012 |
| Z-1994-2012 | Class II | Bayonet Forceps 7.75" (196.9 mm) 0.5 mm Tips N... | Jun 1, 2012 |
| Z-1999-2012 | Class II | Irrigating Bayonet Forceps 8.25" (209.6 mm) 1.5... | Jun 1, 2012 |
| Z-1995-2012 | Class II | Bayonet Forceps 8.5" (215.9mm) Serrated 1.0 mm ... | Jun 1, 2012 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.