The Recall Desk
ModerateFDA (Devices)·Z-0782-2018·Announced 2018-03-07

Avid Medical Recalls Obstetrical Packs With Foreign Material in Needles

Avid Medical is recalling obstetrical convenience kits because some contain needles with loose polypropylene foreign material above release specifications.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The source text does not report any illnesses, injuries, or hospitalizations, and the hazard involves foreign material in non-sterile needles, which fits the criteria for a moderate severity recall without reported harm.

Plain-English summary

Avid Medical, Inc. is recalling 48 units of AVID TruCustom OBSTETRICAL PACK convenience kits, Item Code HLDH008-04. The recall involves specific lots with expiration dates of December 1, 2017, and January 1, 2018.

The recall was initiated because certain kits contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the release specification. The affected products were distributed in 10 states: Illinois, Kentucky, Louisiana, Massachusetts, Missouri, New York, Ohio, Texas, Virginia, and Wisconsin.

Healthcare providers and consumers should stop using these specific kits and contact Avid Medical, Inc. for instructions on return or replacement. This recall is classified as Class II by the FDA.

The recalled product

Product
AVID TruCustom OBSTETRICAL PACK convenience kits, Item Code: HLDH008-04
Manufacturer
Avid Medical, Inc.
Affected units
48

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

  • Lot
  • Expiration Date: 1203562
  • 12/1/2017
  • 1206458
  • 1/1/2018

Distribution

Distributed in 10 states:

Part of a larger recall action

This product is one of 23 recalled by Avid Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 23 products in this recall →