CLASS II Device recall · Reported 13 Nov 2019 · FDA Enforcement Report
Cardinal Health Brand/ sterile recalled by Thermo Fisher Scientific
Thermo Fisher Scientific (Monterrey) is recalling Cardinal Health Brand/ sterile, individual peel pouch specimen container with orange cap, distributed in Ohio. The recall was initiated on 18 Jul 2019 and the FDA has classified it as Class II.
Check your package
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-0273-2020
- 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
- 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, individual peel pouch specimen container with orange cap (100/pk) Catalog number: CHB13905
Where it was distributed
OH
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 # 1237250, 1238659, 1239271, 1240169, 1241734, 1246082, 1248994, 1250049, 1250718, 1251449, 1252504
Where was it sold?
OH
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| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Cardinal Health Brand/ sterile specimen container recalled | Thermo Fisher Scientific (Monterrey) | Foreign Material | OH |
More recalls from Thermo Fisher Scientific (Monterrey)
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Samco Bio-Tite Sterile Specimen Container/, Bio-Tite Blue Cap recalled | Thermo Fisher Scientific (Monterrey) | Sterility | IL, KY, TX |
| Device | CLASS II | Cardinal Health Brand/ sterile specimen container recalled | Thermo Fisher Scientific (Monterrey) | Foreign Material | OH |
Other Other Medical Devices recalls
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|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |