The Recall Desk
ModerateFDA (Devices)·Z-0272-2020·Announced 2019-11-13

Thermo Fisher Recalls Cardinal Health Sterile Specimen Containers

Thermo Fisher Scientific is recalling Cardinal Health sterile specimen containers that may contain plastic shavings on threaded surfaces.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves potential foreign material (plastic shavings) without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Thermo Fisher Scientific is recalling Cardinal Health Brand 120mL/53mm sterile specimen containers with orange caps. The recall involves 2,979,600 units distributed in Ohio.

The containers are being recalled because they may potentially contain plastic shavings on the threaded surfaces between the closure and the vial. Specific lot numbers are listed in the official recall notice.

Healthcare facilities and consumers who have these specific containers should stop using them and contact the recalling firm for instructions on return or replacement.

The recalled product

Product
Cardinal Health Brand 120mL/53mm sterile specimen container with orange cap, 75 pieces/pack, 4 packs/case Catalog number: CHB13904
Manufacturer
Thermo Fisher Scientific (Monterrey)
Category
Medical Device — Specimen Containers
Hazard
Affected units
2,979,600

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 (20)

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

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 2 recalled by Thermo Fisher Scientific (Monterrey) 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 2 products in this recall →

Related recalls

Same manufacturer · Thermo Fisher Scientific (Monterrey)

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Same hazard · foreign material

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