The Recall Desk
HighFDA (Devices)·Z-0318-2018·Announced 2018-01-17

Repro-Med HIgH-Flo Subcutaneous Safety Needle Sets Recalled for Packaging Defects

Repro-Med Systems is recalling HIgH-Flo Subcutaneous Safety Needle Sets because gaps were found in the sterile barrier packaging during post-sterilization inspection.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a sterile medical device where the sterile barrier was compromised, creating a risk of infection or harm. This fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Repro-Med Systems, Inc. is recalling HIgH-Flo Subcutaneous Safety Needle Sets, 2-Needle Set/ 24 Gauge 9mm Needles. The recall includes specific reference and part numbers such as RMS22606, RMS22609, and RMS22612, among others listed in the agency record. The affected products were distributed nationwide in the US.

The recall was initiated after the firm discovered gaps in the sterile barrier packaging during a post-sterilization inspection of a related component, Precision Flow Rate Tubing. During this inspection of Lot 1.042/16, 701 out of 3,195 units were rejected due to visual defects in the manufacturing seal. The firm determined that the issue extended beyond the single lot of tubing and decided to recall the needle sets to ensure product sterility and safety.

The recall was conducted via a Voluntary Medical Device Corrections and Removal Notification to customers on March 10, 2016. The source text notes that this recall was conducted without prior FDA notification. Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed in the official recall notice and contact the manufacturer for instructions on returning or replacing the affected units.

The recalled product

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, RMS3
Manufacturer
Repro-Med Systems, Inc.
Category
Medical Device — Needles and Syringes
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Repro-Med Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Repro-Med Systems, Inc.

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Same hazard · sterility compromise

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