Z-0318-2018Class II

HIgH-Flo Subcutaneous Safety Needle Sets, 2-Needle Set/ 24 Gauge 9mm Needles, REF/Part Numbers RMS22606...

Name: Z-0318-2018 HIgH-Flo Subcutaneous Safety Needle Sets, 2-Needle Set/ 24 Gauge 9mm Needles, REF/Part Numbers RMS22606...
Creator: Repro-Med Systems, Inc.
Published: 2016-03-10
License: https://open.fda.gov/license/

Repro-Med Systems, Inc. / initiated 2016-03-10 / Terminated / root cause: manufacturing process

FDA source

Repro-Med Systems, Inc. began a recall of HIgH-Flo Subcutaneous Safety Needle Sets, 2-Needle Set/ 24 Gauge 9mm Needles, REF/Part Numbers RMS22606, RMS22609, RMS22612, RMS12606, RMS22409, RMS32609... on 2016-03-10. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0318-2018
Classification: Class II
Status: Terminated
Initiated: 2016-03-10
Posted: 2018-01-05
Terminated: 2018-02-26
Recalling firm: Repro-Med Systems, Inc.
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.
Product code: FPA Set, Administration, Intravascular
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On March 10, 2016 RMS Medical Products distributed Urgent Voluntary Medical Device Corrections and Removal notices to their customers. On March 12, 2016 & on March 18, 2016, RMS Medical Products distributed a 2nd Urgent Voluntary Medical Device Corrections and Removal notices to their customers advising them that affected products list was reduced after a comprehensive risk assessment was performed. Customers are advised to check stock, quarantine, cease distribution and remove product from use. If customers further distributed product, they are also encouraged to inform the affected parties. Customers are encouraged to complete and return the acknowledgement form via fax to: 845-469-5518.
Distribution: Nationwide in US
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0318-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0317-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-17	2018-01-05
Z-0318-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-17	2018-01-05

Product code FPA

K122404Class IIModel Number: Rms1-2604, Rms1-2614, Rms1-2404, Rms1-2414, Rms2-2604, Rms2-2614, Rms2-2404, Rms2-2414, Rms3-2604, Rms3-26Repro-Med Systems, Inc. Dba Rms Medical Products / cleared 2013-05-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)