Avid Medical Recalls Pacemaker Tray Kits with Foreign Material
Avid Medical is recalling 70 TruCustom Pacemaker Tray kits because they may 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 specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Avid Medical, Inc. is recalling 70 units of AVID TruCustom PACEMAKER TRAY convenience kits, Item Codes LAKC020-08 and LAKC020-09. 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 1198747 (11/1/2018), 1199952 (10/1/2018), and 1219974 (1/1/2019).
Healthcare providers and consumers should check their inventory for these specific item codes and lot numbers. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations.
The recalled product
- Product
- AVID TruCustom PACEMAKER TRAY convenience kits, Item Code: LAKC020-08 and LAKC020-09
- Manufacturer
- Avid Medical, Inc.
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 70
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: 1198747
- 11/1/2018
- 1199952
- 10/1/2018
- 1219974
- 1/1/2019
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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