Empty Solution Transfer Container 1000

• • Terminated Z-3240-2017 FDA Class II ·initiated 13 Sep 2017

  The hot stamp label on the bag incorrectly states the material of the vinyl (bag) container. The bags are correctly made with PVC material, as ordered and as labeled on the inner and outer boxes.

• • Terminated Z-2261-2016 FDA Class II ·initiated 23 Jun 2016 ·on shared 510(k) K843523

  An issue was identified after a redesign of the auto compounding device. The compounder cannot meet the designed accuracy specification when dispensing into bags. After reviewing the initial design of the device, it was determined the dispensing volume validation was not properly done and none of the compounders on the market can meet the stated specifications.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K843523 ↗

FDA Product Code

KPE

Device Class

Class II

Regulation

21 CFR Part 880.5025

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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See all devices from Polymer Technology Corp. →

• What is the Empty Solution Transfer Container 1000 used for?

  The Empty Solution Transfer Container 1000 is designed as an intravenous (I.V.) container for transferring and storing intravenous solutions in clinical settings. It facilitates the preparation and administration of fluids by ensuring compatibility with intravenous therapy systems. The container is intended to be sterilized and filled with solutions before use, making it ideal for hospital environments where fluid management is critical.

• Is the Empty Solution Transfer Container 1000 sterile when supplied?

  No, the Empty Solution Transfer Container 1000 is supplied in a non-sterile state. It must be sterilized and filled with intravenous solutions prior to clinical use. This ensures safety and compliance with medical standards before administration to patients.

• Can the Empty Solution Transfer Container 1000 be reused?

  No, the Empty Solution Transfer Container 1000 is intended for single-use only. Reuse is not recommended or supported by its design or regulatory classification, as it could compromise sterility and patient safety.

• What regulatory approval does the Empty Solution Transfer Container 1000 hold?

  The Empty Solution Transfer Container 1000 is cleared by the FDA under the 510(k) pathway (K843523) as a Class II medical device. This clearance confirms it meets regulatory standards for intravenous containers, ensuring its safety and effectiveness for clinical use.

• How is the Empty Solution Transfer Container 1000 supplied, and what are its key specifications?

  The container is supplied as a non-sterile, empty unit that must be sterilized and filled with intravenous solutions before use. It is manufactured by Polymer Technology Corp. and adheres to FDA standards for intravenous containers. The device is classified under product code KPE and is intended exclusively for single-use in intravenous therapy systems.