FDA-Device2018-03-07Class II

AVID TruCustom HEART CATH TRAY convenience kits, Item Code: LAKC022-06

Avid Medical, Inc.
Hazard

Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the release specification.

Sold states
Distributed in 10 states: IL, KY, LA, MA, MO, NY, OH, TX, VA, WI.
Affected count
354
Manufactured in
9000 Westmont Dr, N/A, Toano, VA, United States
Products
AVID TruCustom HEART CATH TRAY convenience kits, Item Code: LAKC022-06

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0784-2018

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