Freedom60 Precision Flow Rate Tubing Sets, REF/Part Numbers F900, F2400, F60, F10, F275, F600, F45, F1200 F180.
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0317-2018.
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.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0317-2018.
Recall terminated by FDA.
🩺 Talk to your doctor or pharmacist
Product Recall Tracker does not provide medical advice. Any specific instructions about this medication or device come directly from the FDA notice above. Before making any change to your treatment:
- Do not stop, change, or discard your prescription on your own.
- Call your doctor or pharmacist and ask whether this FDA notice applies to your prescription (have the brand name, dosage, and lot number ready if you can find them).
- Follow your clinician's guidance on whether to continue, switch, or return the product.
- If you have experienced a reaction, seek medical care and report it to the FDA via MedWatch.
- For the official FDA notice, visit the FDA recalls page.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0317-2018.
Repro-Med Systems, Inc.
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If you had an adverse reaction, side effect, or device malfunction from this medication or device, report it to the FDA through MedWatch. Talk to your doctor or pharmacist first — do not stop a prescription on your own. Reports help the FDA detect rare or emerging safety signals and can lead to label changes or recalls.
Repro-med Systems, Inc. Recall FAQ
Repro-med Systems, Inc. is the subject of a medical devices safety report: Freedom60 Precision Flow Rate Tubing Sets, REF/Part Numbers F900, F2400, F60, F10, F275, F600, F45, F1200 F180.. The notice was published on March 10, 2016 by the U.S. Food and Drug Administration (FDA). Approximately 0 units are potentially affected.