Z-0273-2020Class II

Cardinal Health Brand 120mL/53mm sterile, individual peel pouch specimen container with orange cap (100/pk)...

Name: Z-0273-2020 Cardinal Health Brand 120mL/53mm sterile, individual peel pouch specimen container with orange cap (100/pk)...
Creator: Thermo Fisher Scientific (Monterrey)
Published: 2019-07-18
License: https://open.fda.gov/license/

Thermo Fisher Scientific (Monterrey) / initiated 2019-07-18 / Terminated / root cause: manufacturing process

FDA source

Thermo Fisher Scientific (Monterrey) began a recall of Cardinal Health Brand 120mL/53mm sterile, individual peel pouch specimen container with orange cap (100/pk) Catalog number: CHB13905 on 2019-07-18. FDA classified it as Class II and gives the reason as "Cardinal Health branded specimen containers, may potentially contain plastic shavings on threaded surfaces between the closure and vial". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0273-2020
Classification: Class II
Status: Terminated
Initiated: 2019-07-18
Posted: 2019-11-01
Terminated: 2020-05-18
Recalling firm: Thermo Fisher Scientific (Monterrey)
Product: Cardinal Health Brand 120mL/53mm sterile, individual peel pouch specimen container with orange cap (100/pk) Catalog number: CHB13905
Product code: FMH Container, Specimen, Sterile
Reason for recall: Cardinal Health branded specimen containers, may potentially contain plastic shavings on threaded surfaces between the closure and vial
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: 1. Please notify to any organizations that have received affected product. 2. If you have any affected product please contact Technical Support Team regarding free-of-charge product replacement. Technical Support: Phone - +1-800-625-4327 Email - [email protected]
Quantity in commerce: 514,200 each
Distribution: OH
Product codes and lots: Lot # 1237250, 1238659, 1239271, 1240169, 1241734, 1246082, 1248994, 1250049, 1250718, 1251449, 1252504

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0273-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0272-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-13	2019-11-01
Z-0273-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-13	2019-11-01

Product code FMH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)