HIgH-Flo Subcutaneous Safety Needle Sets — Class II medical device recall Z-0318-2018
Terminated recall by Repro-Med Systems, Inc., reported 2018-01-17, distributed nationwide. On 2/24/2016 during post sterilization inspection of part number F180 Precision Flow Rate Tubing, Lot number 1
| Recall number | Z-0318-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Repro-Med Systems, Inc., Chester, NY, United States |
| Recall initiated | 2016-03-10 |
| Classified | 2018-01-05 |
| Reported by FDA | 2018-01-17 |
| Terminated | 2018-02-26 |
| Distributed | Nationwide (US) |
| Reason classes | sterility, packaging |
| Lot numbers | 2019-02, 7.046/16, 7.048/16, 7.049/16, 7.050/16, 7.051/16, 7.052/16, 7.053/16, 7.054/16, 7.055/16, 7.056/16, 7.057/16, 7.058/16, 7.059/16, 7.060/16, 7.061/16, 7.062/16, 7.063/16, 7.064/16, 7.065/16, 7.066/16, 7.068/16, 7.069/16 |
| Model numbers | RMS12406, RMS12409, RMS12412, RMS12606, RMS12609, RMS22409, RMS22412, RMS22606, RMS22609, RMS22612, RMS32609, RMS32612, RMS42606, RMS42609, RMS42612, RMS52612, RMS62606, RMS62609, RMS62612 |
Product
HIgH-Flo Subcutaneous Safety Needle Sets, 2-Needle Set/ 24 Gauge 9mm Needles, REF/Part Numbers RMS22606, RMS22609, RMS22612, RMS12606, RMS22409, RMS32609, RMS32609, RMS12409, RMS12609, RMS62612, RMS62606, RMS12406, RMS22412, RMS12412, RMS42606, RMS62609, RMS52612, RMS42612, RMS32609, RMS22609, RMS22606, RMS42609 & RMS32612.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0318-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.