Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devi...
FDA Device Recall #Z-2721-2014 — Class II — May 30, 2014
Recall Summary
| Recall Number | Z-2721-2014 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 30, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Instrumed International, Inc. |
| Location | Schaumburg, IL |
| Product Type | Devices |
| Quantity | 65 instruments |
Product Description
Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/ urologic closed and minimally invasive procedures. It is inserted via a trocar sleeve and is used to prepare, coagulate and cut tissue.
Reason for Recall
Additional caution statements have been added to the Instructions For Use for monopolar electrodes. 1) To avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak voltage (Vp) for all monopolar electrodes. and 2) For all monopolar electrodes, the useful life of this product is less than or equal to 50 cycles and less than or equal to 2 years.
Distribution Pattern
Distribution US Nationwide in the states of: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY.
Lot / Code Information
1) Instrumed Item No.: 250-08800; Adler Instrument Company Catalog Code: 70-0300; Lot Number: 070113; 2) Instrumed Item No.: 250-08860 ; Adler Instrument Company Catalog Code: 70-0319; Lot Number: 030312, 070411; 3) Instrumed Item No.: 250-08930; Adler Instrument Company Catalog Code: 70-0318; Lot Number: 010113, 020113, 030112, 050412, 060413, 070512, 090213, 100113, 100411; 4) Instrumed Item No.: 250-08960 ; Adler Instrument Company Catalog Code: AD98-1008; Lot Number: 090310; 5) Instrumed Item No.: 250-09010 ; Adler Instrument Company Catalog Code: 70-0317; Lot Number: 100211
Other Recalls from Instrumed International, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0546-2015 | Class II | D'errico perforator drills are bone cutting and... | Sep 8, 2014 |
| Z-0534-2015 | Class II | A zipser clamp is an instrument used to compres... | Sep 8, 2014 |
| Z-0547-2015 | Class II | McKenzie enlarging burrs are bone cutting and d... | Sep 8, 2014 |
| Z-0550-2015 | Class II | Gardner-Wells traction tongs are skull tongs fo... | Sep 8, 2014 |
| Z-0548-2015 | Class II | Hudson cranial drill sets (w/ brace and 5 attac... | Sep 8, 2014 |
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.