Warning
Windstone Medical Packaging Recalls Custom Convenience Kits Pre Op Kit - NS
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #Z-1919-2026Medical Device
Windstone Medical Packaging Recalls Custom Convenience Kits Pre Op Kit - NS
Windstone Medical Packaging, Inc. · Class II — Moderate Risk
Product Description
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14433
Reason for Recall
The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets utilized with BBMI s Infusomat Space Large Volume Pump, Outlook Pump and Vista Basic Pump due to potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers or other connections and the ability to prime (occlusion).
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
US Nationwide distribution in the states of GA, OR, TN, and WA.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
Sources: FDA openFDA Enforcement Database