Avid Medical Recalls Pacemaker Kits With Foreign Material
Avid Medical is recalling 8 TruCustom Pacemaker Packs containing 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 no injuries or illnesses have been reported in the source text.
Plain-English summary
Avid Medical, Inc. is recalling 8 units of AVID TruCustom PACEMAKER PACK (CARDIOLOGY) convenience kits, Item Code VAMK016. The recall involves kits distributed in Illinois, Kentucky, Louisiana, Massachusetts, Missouri, New York, Ohio, Texas, Virginia, and Wisconsin.
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 lot number is 1211878, with an expiration date of July 1, 2018.
Healthcare providers and consumers should stop using these specific kits and contact Avid Medical for further instructions.
The recalled product
- Product
- AVID TruCustom PACEMAKER PACK (CARDIOLOGY) convenience kits, Item Code: VAMK016
- Manufacturer
- Avid Medical, Inc.
- Hazard
- Affected units
- 8
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 (3)
- Lot
- Expiration Date: 1211878
- 7/1/2018
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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