Civco Belly Board, Reusable non-sterile carbon fiber belly board with cushion, REF 125012, packag...

FDA Device Recall #Z-0802-2014 — Class II — October 25, 2013

Recall Summary

Recall Number Z-0802-2014
Classification Class II — Moderate risk
Date Initiated October 25, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Civco Medical Instruments Inc
Location Kalona, IA
Product Type Devices
Quantity 138 belly boards

Product Description

Civco Belly Board, Reusable non-sterile carbon fiber belly board with cushion, REF 125012, packaged 1 per box. Product Usage: This device is intended to reduce the irradiated small bowel volume of gynecological patients undergoing treatment in the pelvic region.

Reason for Recall

Scales adhered to the product may be misaligned from the zero reference such that one side will not match the other.

Distribution Pattern

Worldwide Distribution - USA Nationwide in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, KS, MA, MD, MI, MN, MT, NC, NJ, NY, OH, OK, PA, SC, TN, TX, VA, WA, WI, and WV. Foreign distribution was made to Brazil, Canada, Chile, Czech Republic, France, Germany, Iraq, Israel, Italy, Japan, Malaysia, Saudi Arabia, Slovenia, South Korea, Spain, Turkey, and United Arab Emirates.

Lot / Code Information

Lot #'s: M441670, M469970, M469980, M469990, M484910, M484920, M516200, M516210, M516220, M533340, M533350, M533360, M533370, M533380, M533970, M533980, M533990, M534000, M544650, M544660, M544670, M550150, M551490, M554940, M554950, M556540, M556550, M559560, M560740, M575850, M578310, M581730, M591090, M591100, M591110, M591120, M591130, and M599570

Other Recalls from Civco Medical Instruments Inc

Recall # Classification Product Date
Z-1400-2015 Class II CIVCO Surgi-Tip Transducer Cover Sterile (15.2 ... Feb 26, 2015
Z-2558-2014 Class II CollectEVAC, Sterile device with tubing and ada... Aug 1, 2014
Z-0803-2014 Class II Civco Belly Board MRI, Reusable non-sterile gla... Oct 25, 2013
Z-1956-2012 Class II CIVCO VirtuTRAX Instrument Navigator, Reusable ... May 7, 2012
Z-1953-2012 Class II CIVCO General Purpose Sensor, Non-sterile reusa... May 7, 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.