The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0796-2018·Announced 2018-03-07

Avid Medical Recalls TruCustom Pacemaker Kits Due to Foreign Material

Avid Medical is recalling 90 TruCustom Pacemaker Pack convenience kits because they may contain loose polypropylene foreign material in the included needles.

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 is classified as FDA Class II and involves a medical device with a risk of harm (foreign material) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Avid Medical, Inc. is recalling 90 units of AVID TruCustom PACEMAKER PACK convenience kits, Item Code: LGHM030-06. The recall affects kits with lot numbers 1198253 (expiration date 9/1/2018) and 1213945 (expiration date 7/1/2018). These kits were distributed in 10 states: Illinois, Kentucky, Louisiana, Massachusetts, Missouri, New York, Ohio, Texas, Virginia, and Wisconsin.

The recall was initiated because certain kits contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the release specification. The FDA has classified this recall as Class II, indicating a situation in which use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Healthcare providers and patients who have received these specific kits should stop using them and contact Avid Medical, Inc. for instructions on return or replacement. Consumers should verify the lot numbers and expiration dates against the information provided in this notice to determine if their products are affected.

The recalled product

Product
AVID TruCustom PACEMAKER PACK convenience kits, Item Code: LGHM030-06
Manufacturer
Avid Medical, Inc.
Category
Medical Device — Pacemaker Accessories
Hazard
Affected units
90

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 (5)

  • Lot
  • Expiration Date: 1198253
  • 9/1/2018
  • 1213945
  • 7/1/2018

Distribution

Distributed in 10 states:

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.

See all 23 products in this recall →

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