PlainRecalls
FDA Devices Moderate Class II Terminated

AVID TruCustom OBSTETRICAL PACK convenience kits, Item Code: HLDH008-04

Reported: March 7, 2018 Initiated: June 22, 2017 #Z-0782-2018

Product Description

AVID TruCustom OBSTETRICAL PACK convenience kits, Item Code: HLDH008-04

Reason for Recall

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.

Details

Recalling Firm
Avid Medical, Inc.
Units Affected
48
Distribution
Distributed in 10 states: IL, KY, LA, MA, MO, NY, OH, TX, VA, WI.
Location
Toano, VA

Frequently Asked Questions

What product was recalled?
AVID TruCustom OBSTETRICAL PACK convenience kits, Item Code: HLDH008-04. Recalled by Avid Medical, Inc.. Units affected: 48.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on March 7, 2018. Severity: Moderate. Recall number: Z-0782-2018.