Freedom60 Precision Flow Rate Tubing Sets, REF/Part Numbers F900, F2400, F60, F10, F275, F600, F4...
FDA Device Recall #Z-0317-2018 — Class II — March 10, 2016
Recall Summary
| Recall Number | Z-0317-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 10, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Repro-Med Systems, Inc. |
| Location | Chester, NY |
| Product Type | Devices |
| Quantity | N/A |
Product Description
Freedom60 Precision Flow Rate Tubing Sets, REF/Part Numbers F900, F2400, F60, F10, F275, F600, F45, F1200 F180.
Reason for Recall
On 2/24/2016 during post sterilization inspection of part number F180 Precision Flow Rate Tubing, Lot number 1.042/16 the firm found 701 out of 3,195 were rejected due to visual defect, gap in the supplier s manufacturing seal for Part number #317036 5 X 6.5 ST Bag Combo. the firm decided to recall Precision Flow Rate Tubing and RMS HIgH-Flo Subcutaneous Safety Needles Sets due to the sterile barrier packaging being found to have gaps during post-sterilization inspection of one lot of flow tubing, in which 701 out of 3,195 units were rejected for not passing inspection. The firm determined that the issue was large than just the one lot and recalled the product via March 10, 2016 Voluntary Medical Device Corrections and Removal Notification to customers. The recall was conducted without FDA notification.
Distribution Pattern
Nationwide in US
Lot / Code Information
Lot Numbers: 1.053/16, 1.052/16, 1.051/16, 1.050/16, 1.049/16, 1.048/16, 1.047/16, 1.042/16, 1.041/16, 1.040/16, 1.039/16, 1.038/16, 1.037/16, 1.036/16, 1.033/16, & 1.030/16 Expiration: 2021-02
Other Recalls from Repro-Med Systems, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0051-2020 | Class II | 20" 2-Needle 26-Gauge 6mm HlgH-Flo Subcutaneous... | Aug 20, 2019 |
| Z-0318-2018 | Class II | HIgH-Flo Subcutaneous Safety Needle Sets, 2-Nee... | Mar 10, 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.