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.
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 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.
- Category
- Medical Device — Surgical Kits
- Hazard
- 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
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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