CLASS II Device recall · Reported 7 Mar 2018 · FDA Enforcement Report

Avid TruCustom Pacemaker Pack convenience kits recalled by Avid Medical

Avid Medical is recalling Avid TruCustom Pacemaker Pack convenience kits, distributed in 10 states. The recall was initiated on 22 Jun 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot, Expiration Date: 1198253, 9/1/2018; 1213945, 7/1/2018

Quantity recalled90

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0796-2018
FDA event ID: 79162
Recalling firm: Avid Medical, Toano, VA
Classification: Class II
Status: Terminated
Recall initiated: 22 Jun 2017
FDA classified: 28 Feb 2018
Reported: 7 Mar 2018
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Foreign Material
Device type: Pacemakers & Defibrillators

Timeline

22 Jun 2017	Recall initiated by company
28 Feb 2018	Classified by FDA	+251 days
7 Mar 2018	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the release specification.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

AVID TruCustom PACEMAKER PACK convenience kits, Item Code: LGHM030-06

Where it was distributed

Distributed in 10 states: IL, KY, LA, MA, MO, NY, OH, TX, VA, WI.

Illinois Kentucky Louisiana Massachusetts Missouri New York Ohio Texas Virginia Wisconsin

Questions about this recall

Is Avid TruCustom Pacemaker Pack convenience kits recalled?

Yes. Avid Medical recalled Avid TruCustom Pacemaker Pack convenience kits on 22 Jun 2017. The recall is Class II and its status is Terminated. Recall number Z-0796-2018.

Why was it recalled?

Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the release specification.

Which lots are affected?

Lot, Expiration Date: 1198253, 9/1/2018; 1213945, 7/1/2018

Where was it sold?

Distributed in 10 states: IL, KY, LA, MA, MO, NY, OH, TX, VA, WI.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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