The Recall Desk
HighFDA (Devices)·Z-0273-2020·Announced 2019-11-13

Thermo Fisher Recalls Cardinal Health Specimen Containers Due to Plastic Shavings

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

What this means for you

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 the hazard involves potential foreign material (plastic shavings) in a sterile medical device, which poses a risk of harm even without reported injuries.

Plain-English summary

Thermo Fisher Scientific is recalling Cardinal Health Brand 120mL/53mm sterile, individual peel pouch specimen containers with orange caps (Catalog number: CHB13905). The recall involves 514,200 units distributed in Ohio.

The recall was initiated because the containers may potentially contain plastic shavings on the threaded surfaces between the closure and the vial. The affected lots are 1237250, 1238659, 1239271, 1240169, 1241734, 1246082, 1248994, 1250049, 1250718, 1251449, and 1252504.

The FDA has classified this as a Class II recall. Users should check their inventory for the specific catalog number and lot numbers listed above.

The recalled product

Product
Cardinal Health Brand 120mL/53mm sterile, individual peel pouch specimen container with orange cap (100/pk) Catalog number: CHB13905
Manufacturer
Thermo Fisher Scientific (Monterrey)
Category
Medical Device — Specimen Containers
Hazard
Affected units
514,200

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 (11)

  • Lot # 1237250
  • 1238659
  • 1239271
  • 1240169
  • 1241734
  • 1246082
  • 1248994
  • 1250049
  • 1250718
  • 1251449
  • 1252504

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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