Reported Jan 17, 2018 · Terminated
HIgH-Flo Subcutaneous Safety Needle Sets, 2-Needle Set/ 24 Gauge 9mm Needles, REF/Part Numbers RMS22606, RMS22609,…
Repro-Med Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Repro-Med Systems, Inc. · 24 Carpenter Rd · Chester, NY · 10918-1057
Is this the product you have?
HIgH-Flo Subcutaneous Safety Needle Sets2-Needle Set/ 24 Gauge 9mm NeedlesREF/Part Numbers RMS22606RMS22609RMS22612RMS12606RMS22409RMS32609RMS32609RMS12409RMS12609RMS62612RMS62606RMS12406RMS22412RMS12412RMS42606RMS62609RMS52612RMS42612RMS32609RMS22609RMS22606RMS42609 & RMS32612
- Lot codes and dates
- Lot Numbers
7.069/167.068/167.066/167.065/167.064/167.063/167.062/167.061/167.060/167.059/167.058/167.057/167.056/167.055/167.054/167.053/167.052/167.051/167.050/167.049/167.048/16 & 7.046/16
- Expiration2019-02
- Lot Numbers
- Amount recalled
- N/A
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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