Avid Medical Recalls TruCustom Ortho Tray Kits Due to Foreign Material
Avid Medical is recalling 597 TruCustom Ortho Tray kits because they may 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 specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Avid Medical, Inc. is recalling 597 units of AVID TruCustom ORTHO TRAY convenience kits (Item Codes LGHM004-07 and LGHM004-08). 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. Specific lot numbers and expiration dates include 1194408 (10/1/2018), 1204116 (10/1/2018), 1216669 (12/1/2018), and 1216670 (11/1/2018).
Consumers and healthcare providers should stop using these kits and contact Avid Medical for further instructions.
The recalled product
- Product
- AVID TruCustom ORTHO TRAY convenience kits, Item Code: LGHM004-07 and LGHM004-08
- Manufacturer
- Avid Medical, Inc.
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 597
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: 1194408
- 10/1/2018
- 1204116
- 1216669
- 12/1/2018
- 1216670
- 11/1/2018
Distribution
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.
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