CLASS II Device recall · Reported 13 Nov 2019 · FDA Enforcement Report

Cardinal Health Brand/ sterile specimen container recalled

Thermo Fisher Scientific (Monterrey) is recalling Cardinal Health Brand/ sterile specimen container with orange cap/pack/case, distributed in Ohio. The recall was initiated on 18 Jul 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot # 1236428, 1237502, 1237804, 1238412,1238880, 1239711, 1241129, 1242233, 1243303,1243863, 1246080,1246545,1247463,1248348, 1248489, 1249612, 1250496,1250723, 1251447,1251519, 1251993, 1253294

Quantity recalled2,979,600 each

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-0272-2020
FDA event ID: 83762
Recalling firm: Thermo Fisher Scientific (Monterrey), Apodaca Nuevo Leon 66600, N/A
Classification: Class II
Status: Terminated
Recall initiated: 18 Jul 2019
FDA classified: 1 Nov 2019
Reported: 13 Nov 2019
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Foreign Material
Device type: Other Medical Devices

Timeline

18 Jul 2019	Recall initiated by company
1 Nov 2019	Classified by FDA	+106 days
13 Nov 2019	Published in enforcement report	+12 days

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

Reason for recall

Cardinal Health branded specimen containers, may potentially contain plastic shavings on threaded surfaces between the closure and vial

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

Cardinal Health Brand 120mL/53mm sterile specimen container with orange cap, 75 pieces/pack, 4 packs/case Catalog number: CHB13904

Where it was distributed

Ohio

Questions about this recall

Why was it recalled?

Cardinal Health branded specimen containers, may potentially contain plastic shavings on threaded surfaces between the closure and vial

Which lots are affected?

Lot # 1236428, 1237502, 1237804, 1238412,1238880, 1239711, 1241129, 1242233, 1243303,1243863, 1246080,1246545,1247463,1248348, 1248489, 1249612, 1250496,1250723, 1251447,1251519, 1251993, 1253294

Where was it sold?

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.

Other products in this recall event

1 other product · FDA event 83762

This product is part of a recall event; the main page for the event is Cardinal Health Brand/ sterile recalled by Thermo Fisher Scientific.

Reported	Class	Recall	Company	Reason	Where
13 Nov 2019	CLASS II	Cardinal Health Brand/ sterile recalled by Thermo Fisher Scientific	Thermo Fisher Scientific (Monterrey)	Foreign Material	OH

More recalls from Thermo Fisher Scientific (Monterrey)

All 3

Reported	Class	Recall	Company	Reason	Where
3 Jun 2020Device	CLASS II	Samco Bio-Tite Sterile Specimen Container/, Bio-Tite Blue Cap recalled	Thermo Fisher Scientific (Monterrey)	Sterility	IL, KY, TX
13 Nov 2019Device	CLASS II	Cardinal Health Brand/ sterile recalled by Thermo Fisher Scientific	Thermo Fisher Scientific (Monterrey)	Foreign Material	OH

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