The Recall Desk
HighFDA (Devices)·Z-0798-2018·Announced 2018-03-07

Avid Medical Recalls TruCustom Plastic Basin Kits Due to Foreign Material

Avid Medical is recalling 440 TruCustom Plastic Basin Packs because some kits contain needles with 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 injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Avid Medical, Inc. is recalling 440 units of AVID TruCustom PLASTIC BASIN PACK convenience kits, Item Code: MADN008-03. The recall is due to the presence of loose polypropylene foreign material in certain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles packed within the kits. This foreign material exceeds the release specification.

The affected products were distributed in 10 states: Illinois, Kentucky, Louisiana, Massachusetts, Missouri, New York, Ohio, Texas, Virginia, and Wisconsin. The specific lot numbers and expiration dates involved are 1203380 (8/1/2018), 1203381 (8/1/2018), 1203382 (12/1/2018), and 1211709 (12/23/2018).

Healthcare facilities and consumers should stop using these kits and contact Avid Medical, Inc. for further instructions or a return.

The recalled product

Product
AVID TruCustom PLASTIC BASIN PACK convenience kits, Item Code: MADN008-03
Manufacturer
Avid Medical, Inc.
Affected units
440

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 (8)

  • Lot
  • Expiration Date: 1203380
  • 8/1/2018
  • 1203381
  • 1203382
  • 12/1/2018
  • 1211709
  • 12/23/2018

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 →