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.
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 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
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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