Bayonet Forceps 7.-1/8 (181.0mm) 0.75mm Insulated Tips, Sterile Single Use Surgical/Bipolar Forc...
FDA Device Recall #Z-1996-2012 — Class II — June 1, 2012
Recall Summary
| Recall Number | Z-1996-2012 |
| 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 | 80 units |
Product Description
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.
Reason for Recall
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.
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: 20-1360I, Lot Number: 023399, Expiration Date: 02/28/2017.
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-1998-2012 | Class II | Bayonet Forceps 7.-1/8 (181.0mm) 0.75mm Non-Ins... | Jun 1, 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 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
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.