The Recall Desk
HighFDA (Devices)·Z-0365-2020·Announced 2019-11-20

Cadence Science Pressure Control Glass Syringes Recalled for Breakage Risk

Cadence Science is recalling 237 Pressure Control Glass Syringes because they may break during use, posing a potential injury risk to patients and healthcare workers.

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 medical device with a risk of physical injury (glass breakage) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Cadence Science, Inc. is recalling 237 units of Pressure Control Glass Syringes. The affected products include Part Numbers 5338, 5339, 5340, 5341, 5342, and 5343, which are intended for general hospital use. The recall is due to a defect where the glass syringe may potentially break during use.

The recalled syringes were distributed nationwide in the United States, specifically in the states of Alabama, Arkansas, California, Florida, Georgia, Iowa, Idaho, Illinois, Missouri, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Texas, Virginia, and Wisconsin. The agency has classified this as a Class II recall.

Healthcare facilities and consumers should stop using the affected syringes immediately. Users should check their inventory for the specific part numbers and lot codes listed in the recall notice. If the product is found, it should be returned to the manufacturer or disposed of according to local regulations to prevent potential injury from broken glass.

The recalled product

Product
Cadence Science Pressure Control Glass Syringe, Part Nos. 5338 (GTIN #816329023381); 5339 (GTIN #816329023398); 5340 (GTIN #816329023404); 5341 (GTIN #816329023411); 5342 (GTIN #816329023428); 5343 (GTIN #816329023435) - Product Usage: General Hospital Use
Affected units
237

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)

  • Catalog Number 5338: W037053/1
  • W037199/1
  • W037450/1
  • W040276/1
  • W042297/1
  • W040804/1
  • W045558/1
  • W049244/1
  • Catalog Number 5339: W020584/1
  • Catalog Number 5340: W033034/1
  • W046909/1
  • W047793/1
  • W048648/1
  • W049141/1
  • W049853/1
  • W050262/1
  • W051186/1
  • Catalog Number 5341: W029677/1
  • W037708/1
  • W040478/1

Distribution

Distributed nationwide across the United States.

The notice also names 18 states specifically: