Integra¿ Bone Marrow Biopsy Trays Catalogue No. 3404253 Various medical devices and components u...
FDA Device Recall #Z-0193-2016 — Class II — September 22, 2015
Recall Summary
| Recall Number | Z-0193-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | September 22, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Integra LifeSciences Corp. d.b.a. Integra Pain Management |
| Location | Salt Lake City, UT |
| Product Type | Devices |
| Quantity | A total of 470 packages (47 cases) |
Product Description
Integra¿ Bone Marrow Biopsy Trays Catalogue No. 3404253 Various medical devices and components used to perform bone marrow biopsies are placed in a plastic tray which is sealed in an EtO sterilizable pouch. Vials of 1 % Lidocaine HCL Injection, USP, 10 mg/mL (manufactured and distributed by Hospira Inc.) are placed in a separate sealed pouch. After the bone marrow biopsy pouch is sterilized, a Lidocaine pouch is affixed to each. Ten of these pouches are inserted in a sealed and labeled corrugated box.
Reason for Recall
Integra received an Urgent Drug Recall Notice from Hospira Inc. for their 1% Lidocaine HCL Injection, USP, 10 mg/mL, Lot 44-359-DK. Hospira Inc. is recalling vials of Lot 44-359-DK, 1% Lidocaine HCL Injection, USP, 10 mg/mLm distributed by Hospira from February 2015 to March 2015 due to a confirmed complaint of visible, partially embedded particulate within a single-dose glass teartop vial.
Distribution Pattern
US Distributed to the state of : MD.
Lot / Code Information
There are 3 Integra Lot Numbers affected by the recall of the single lot of Hospira Lidocaine: W1501193, W1504141, W1505078 Catalogue No. 3404253
Other Recalls from Integra LifeSciences Corp. d.b.a. Int...
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2868-2016 | Class II | PHS Spinal Tray 24G Gertie Marx, Catalogue No. ... | Aug 24, 2016 |
| Z-2733-2016 | Class II | Integra Cranial Access Kits, Catalogue Nos. INS... | Aug 24, 2016 |
| Z-2684-2016 | Class II | INTEGRA Spinal Tray, Catalogue No: 3404875, Con... | Aug 4, 2016 |
| Z-2056-2015 | Class II | Integra¿ Long Epidural Steroid Injection Needle... | May 1, 2015 |
| Z-1544-2015 | Class II | Integra Long Epidural Steroid Injection Needle ... | Mar 30, 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.