CLASS II Device recall · Reported 17 Jan 2018 · FDA Enforcement Report
Freedom60 Precision Flow Rate Tubing Sets recalled by Repro-Med Systems
Repro-Med Systems is recalling Freedom60 Precision Flow Rate Tubing Sets, distributed nationwide in the US. The recall was initiated on 10 Mar 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0317-2018
- FDA event ID
- 76569
- Recalling firm
- Repro-Med Systems, Chester, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Mar 2016
- FDA classified
- 5 Jan 2018
- Reported
- 17 Jan 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 10 Mar 2016 | Recall initiated by company | |
| 5 Jan 2018 | Classified by FDA | +666 days |
| 17 Jan 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Freedom60 Precision Flow Rate Tubing Sets, REF/Part Numbers F900, F2400, F60, F10, F275, F600, F45, F1200 F180.
Where it was distributed
Nationwide in US
Questions about this recall
Is Freedom60 Precision Flow Rate Tubing Sets recalled?
Yes. Repro-Med Systems recalled Freedom60 Precision Flow Rate Tubing Sets on 10 Mar 2016. The recall is Class II and its status is Terminated. Recall number Z-0317-2018.
Why was it recalled?
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.
Which lots are affected?
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
Where was it sold?
Nationwide in US
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Repro-Med Systems
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | 20" 2-Needle 26-Gauge HlgH-Flo Subcutaneous Safety Needle recalled | Repro-Med Systems | Labeling Errors | Nationwide |
| Device | CLASS II | HIgH-Flo Subcutaneous Safety Needle Sets, 2-Needle Set/ Needles recalled | Repro-Med Systems | Sterility | Nationwide |
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