The Recall Desk
HighFDA (Devices)·Z-0794-2018·Announced 2018-03-07

Avid Medical Recalls TruCustom Kits With Foreign Material in Needles

Avid Medical is recalling 44 TruCustom Minor Procedure kits because the included needles may contain loose polypropylene foreign material.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a foreign material defect that poses a risk of harm, but the source text does not report any illnesses or injuries, fitting the criteria for a High severity score.

Plain-English summary

Avid Medical, Inc. is recalling 44 units of AVID TruCustom MINOR PROCEDURE 6A convenience kits (Item Code: MADN032-01). The recall is due to the presence of BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the release specification.

The affected kits were distributed in 10 states: Illinois, Kentucky, Louisiana, Massachusetts, Missouri, New York, Ohio, Texas, Virginia, and Wisconsin. The specific lots involved have expiration dates of August 1, 2018, October 1, 2018, and August 1, 2018, with lot numbers 1210946, 1211091, and 1213010, respectively.

Consumers and healthcare providers should stop using these kits and contact Avid Medical for instructions on returning the product.

The recalled product

Product
AVID TruCustom MINOR PROCEDURE 6A convenience kits, Item Code: MADN032-01
Manufacturer
Avid Medical, Inc.
Affected units
44

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 (6)

  • Lot
  • Expiration Date: 1210946
  • 8/1/2018
  • 1211091
  • 10/1/2018
  • 1213010

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 →