Integra Container Lid, ¿¿ Size, Red; Container Lid, ¿¿ Size, Blue; Container Lid, ¿¿ Size, Red; C...
FDA Device Recall #Z-2624-2014 — Class II — July 30, 2014
Recall Summary
| Recall Number | Z-2624-2014 |
| Classification | Class II — Moderate risk |
| Date Initiated | July 30, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Integra York PA, Inc |
| Location | York, PA |
| Product Type | Devices |
| Quantity | 84 |
Product Description
Integra Container Lid, ¿¿ Size, Red; Container Lid, ¿¿ Size, Blue; Container Lid, ¿¿ Size, Red; Container Lid, ¿¿ Size, Gold; Container Lid, ¿¿ Size, Green; Container Lid, Full Size, Blue; Container Lid, Full Size, Red Catalogue Numbers: 730422, 730521, 730522, 730523, 730524, 730621, 730622 The Integra Sterilization Container is intended for use in hospitals and healthcare facilities to contain other medical devices that are to be steam sterilized (autoclaved) by the facility prior to use. Sterilized devices may be stored and transferred within the facility in the container per the healthcare facilities protocols. Integra provides these items to users as either as a tray and lid combination, just a tray, or just a lid.
Reason for Recall
Integra LifeSciences has identified through an internal investigation that some colored lids for Integra container systems were not yet cleared by the FDA for sale and were inadvertently distributed.
Distribution Pattern
US only to one repacker/relabeler and three medical facilities. The relabeler was identified as: KLS Martin, 11201 St. Johns Industrial Parkway S, Jacksonville, FL 32246 (904) 641-7746
Lot / Code Information
Container Lid, ¿ Size, Red; Container Lid, ¿ Size, Blue; Container Lid, ¿ Size, Red; Container Lid, ¿ Size, Gold; Container Lid, ¿ Size, Green; Container Lid, Full Size, Blue; Container Lid, Full Size, Red Catalogue Numbers: 730422, 730521, 730522, 730523, 730524, 730621, 730622
Other Recalls from Integra York PA, Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0751-2017 | Class II | Rochester-Pean Hemostatic Forceps 61/4, Curved,... | Oct 28, 2016 |
| Z-0752-2017 | Class II | Metzenbaum Scissors 7, Curved, Sterile The ... | Oct 28, 2016 |
| Z-1841-2016 | Class II | Miltex Premium Grade Self-Lock Chisel Blade Han... | Mar 11, 2016 |
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.