FDA-Device2015-11-11Class II

Regard Custom Surgical Pack, Item Number 880239, Sterile IV Pack. Custom procedure trays contain surgical instruments and accessories intended for use during a surgical procedure.

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Hazard

The kits contain pressure monitoring kits or sets which are being recalled as a result of flow restriction issues in the trifurcated IV set.

Sold states
Product was distributed to one customer in Oklahoma.
Affected count
255 packs
Manufactured in
2909 N Neergard Ave, N/A, Springfield, MO, United States
Products
Regard Custom Surgical Pack, Item Number 880239, Sterile IV Pack. Custom procedure trays contain surgical instruments and accessories intended for use during a surgical procedure.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0229-2016

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