CIVCO Surgi-Tip Transducer Cover Sterile (15.2 x 244 cm) polyethylene telescopically-folded cover...
FDA Device Recall #Z-1400-2015 — Class II — February 26, 2015
Recall Summary
| Recall Number | Z-1400-2015 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 26, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Civco Medical Instruments Inc |
| Location | Kalona, IA |
| Product Type | Devices |
| Quantity | 120 pouches |
Product Description
CIVCO Surgi-Tip Transducer Cover Sterile (15.2 x 244 cm) polyethylene telescopically-folded cover with attached (3 cm) NeoGuard tip, REF 610-833. Each cover is packaged in a Tyvek pouch with accessories of gel and fasteners. Individual Tyvek pouches are packaged as a box of 12. Rx only. The cover allows use of the transducer in scanning and needle guided procedures for body surface, endocavity and intra-operative diagnostic ultrasound.
Reason for Recall
Leaks were detected in the recalled lot which may compromise the sterility of the product.
Distribution Pattern
Distributed to the states of CA, IL, MA, MI, MO, and WI.
Lot / Code Information
Tyvek pouch - lot M591280; Box lot - M612600 Expiration date 2018.01
Other Recalls from Civco Medical Instruments Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2558-2014 | Class II | CollectEVAC, Sterile device with tubing and ada... | Aug 1, 2014 |
| Z-0802-2014 | Class II | Civco Belly Board, Reusable non-sterile carbon ... | Oct 25, 2013 |
| 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
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.