Medical Device Exchange PhysioMesh Flexible Composite Mesh 10cm x 15cm; Pouch, Tyvek/Mylar, Ste...
FDA Device Recall #Z-2242-2015 — Class II — February 11, 2015
Recall Summary
| Recall Number | Z-2242-2015 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 11, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | EXP Pharmaceutical Services Corp |
| Location | Fremont, CA |
| Product Type | Devices |
| Quantity | 2 |
Product Description
Medical Device Exchange PhysioMesh Flexible Composite Mesh 10cm x 15cm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number PHY1015V; EXP (repackager), Ethicon (OEM) Mesh, surgical, polymeric
Reason for Recall
EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.
Distribution Pattern
Distributed in DC and the states of CO, CA, FL, TX, and AR.
Lot / Code Information
OEM Catalog number PHY1015V.
Other Recalls from EXP Pharmaceutical Services Corp
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2235-2015 | Class II | Medical Device Exchange PT WIRE 300; Pouch, T... | Feb 11, 2015 |
| Z-2247-2015 | Class II | Medical Device Exchange 2.15MMX22MM Fluted Spi... | Feb 11, 2015 |
| Z-2225-2015 | Class II | Medical Device Exchange -Suction Coagulator; ... | Feb 11, 2015 |
| Z-2229-2015 | Class II | Medical Device Exchange ETS FLEX 45 ENDOSCOPIC... | Feb 11, 2015 |
| Z-2244-2015 | Class II | Medical Device Exchange SECURESTRAP 5mm Absorb... | Feb 11, 2015 |
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.