HIgH-Flo Subcutaneous Safety Needle Sets recall: Sterility Concern
HIgH-Flo Subcutaneous Safety Needle Sets, 2-Needle Set/ 24 Gauge 9mm Needles, REF/Part Numbers RMS22606, RMS22609, RMS22612, RMS12606, RMS22409…
Why was HIgH-Flo Subcutaneous Safety Needle Sets 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Numbers: 7.069/16, 7.068/16, 7.066/16, 7.065/16, 7.064/16, 7.063/16, 7.062/16, 7.061/16, 7.060/16, 7.059/16, 7.058/16, 7.057/16, 7.056/16, 7.055/16, 7.054/16, 7.053/16, 7.052/16, 7.051/16, 7.050/16, 7.049/16, 7.048/16 & 7.046/16. Expiration: 2019-02
- Product
- HIgH-Flo Subcutaneous Safety Needle Sets, 2-Needle Set/ 24 Gauge 9mm Needles, REF/Part Numbers RMS22606, RMS22609, RMS22612, RMS12606, RMS22409…
- Recalling firm
- Repro-Med Systems, Inc.
- Quantity
- N/A
- Distribution
- Nationwide in US
- Recall date
- January 17, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)