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