The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0802-2018·Announced 2018-03-07

Avid Medical Recalls TruCustom Upper Extremity Kits Due to Foreign Material

Avid Medical is recalling 216 TruCustom Upper Extremity convenience kits because they may contain loose polypropylene foreign material in the needles.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 is classified as FDA Class II and involves a risk-of-harm product (foreign material in needles) where no specific injuries or illnesses have been reported in the source text.

Plain-English summary

Avid Medical, Inc. is recalling 216 units of AVID TruCustom UPPER EXTREMITY convenience kits, Item Codes LGHM050-03 and LGHM050-04. The recall is due to the presence of loose polypropylene foreign material above release specifications in the BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles contained in certain kits.

The affected lots are 1189012 (expiration 7/1/2019), 1213716 (expiration 9/1/2019), and 1216726 (expiration 10/1/2019). These kits were distributed in 10 states: Illinois, Kentucky, Louisiana, Massachusetts, Missouri, New York, Ohio, Texas, Virginia, and Wisconsin.

Healthcare facilities and consumers should stop using the affected kits and contact Avid Medical, Inc. for instructions on return or replacement. The FDA has classified this as a Class II recall.

The recalled product

Product
AVID TruCustom UPPER EXTREMITY convenience kits, Item Code: LGHM050-03 and LGHM050-04
Manufacturer
Avid Medical, Inc.
Category
Medical Device — Surgical Kits
Hazard
Affected units
216

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 (7)

  • Lot
  • Expiration Date: 1189012
  • 7/1/2019
  • 1213716
  • 9/1/2019
  • 1216726
  • 10/1/2019

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 →

Related recalls

Same manufacturer · Avid Medical, Inc.

See all →

Same hazard · foreign material

See all →

Similar recalls