Device recall: Cardinal Health Brand 120mL/53mm sterile specimen container with orange cap, 75 pieces/pack, 4 packs/case Catalog number
FDA enforcement event 83762 is a device recall by an individual recalling firm (name withheld) of Apodaca Nuevo Leon 66600, N/A, initiated 18 Jul 2019 and classified Class II, with 2 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 968 device enforcement events initiated in 2019 carry the same class.
Status: Terminated, terminated 18 May 2020. Initiation: voluntary: firm initiated.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Individual recalling firm (name withheld), Apodaca Nuevo Leon 66600, N/A, Mexico. FDA names an individual as the recalling firm; this site does not publish people's names.
Reason for recall
"Cardinal Health branded specimen containers, may potentially contain plastic shavings on threaded surfaces between the closure and vial"
Distribution
"OH"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0272-2020 | Cardinal Health Brand 120mL/53mm sterile specimen container with orange cap, 75 pieces/pack, 4 packs/case Catalog number: CHB13904 | 2,979,600 each | Class II | Terminated | 13 Nov 2019 |
| Z-0273-2020 | Cardinal Health Brand 120mL/53mm sterile, individual peel pouch specimen container with orange cap (100/pk) Catalog number: CHB13905 | 514,200 each | Class II | Terminated | 13 Nov 2019 |
Context
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Cardinal Health branded specimen containers, may potentially contain plastic shavings on threaded surfaces between the closure and vial"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "OH"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 18 May 2020. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.