A) Product Code 2N3371: Non-DEHP Y-Type Catheter Extension Set, 5.7", Vol. 0.8 mL, 2 Injection S...
FDA Device Recall #Z-1269-2013 — Class II — March 28, 2013
Recall Summary
| Recall Number | Z-1269-2013 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 28, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Baxter Healthcare Corp. |
| Location | Deerfield, IL |
| Product Type | Devices |
| Quantity | A) Product Code 2N3371: 228,200 units |
Product Description
A) Product Code 2N3371: Non-DEHP Y-Type Catheter Extension Set, 5.7", Vol. 0.8 mL, 2 Injection Sites, Male Luer Lock Adapter, Single use only Product Usage: This device is indicated for use in blood sampling and the administration of solutions. The InterLink Injection Site feature is intended to eliminate accidental needle sticks when used in conjunction with an InterLink Cannula as part of an I.V. needless access system.
Reason for Recall
Customers have reported that when separating an individual package from its attached grouping, the adjacent package has opened, compromising its sterile barrier properties.
Distribution Pattern
Worldwide Distribution - USA Nationwide and the countries of Puerto Rico, Brazil, Canada and Columbia.
Lot / Code Information
A) Product Code 2N3371: Lots R12H23076, R12H30097, R12I0707, R12I08059, R12I25046, R12I2607, R12J11052, R12J12068, R12J13058R12K17057, R12L10084, R13A12057
Other Recalls from Baxter Healthcare Corp.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0370-2017 | Class II | GAMBRO Capillary Dialyzer, Polyflux(R) Revaclea... | Oct 12, 2016 |
| Z-0670-2017 | Class II | sigma spectrum VOLUMETRIC INFUSION PUMP with Ma... | Sep 28, 2016 |
| Z-0671-2017 | Class II | Baxter SIGMA Spectrum INFUSION PUMP with Master... | Sep 28, 2016 |
| Z-0672-2017 | Class II | V6 Rear Case Assembly, Product Code 35701, a re... | Sep 28, 2016 |
| Z-2533-2016 | Class II | Synovis VASCU-GUARD Peripheral Vascular Patch i... | Jun 24, 2016 |
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.