Z-2378-2018Class II

BARD MYPICC Kit, REF CK000095B, 5F French Size, packaged 5 kits/case, Sterile, RX, For use in vascular access...

Name: Z-2378-2018 BARD MYPICC Kit, REF CK000095B, 5F French Size, packaged 5 kits/case, Sterile, RX, For use in vascular access...
Creator: Medline Industries, Inc.
Published: 2018-01-12
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2018-01-12 / Terminated / root cause: manufacturing process

FDA source

Medline Industries, Inc. began a recall of BARD MYPICC Kit, REF CK000095B, 5F French Size, packaged 5 kits/case, Sterile, RX, For use in vascular access procedures on 2018-01-12. FDA classified it as Class II and gives the reason as "One of the cases of product might not have been sterilized". 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-2378-2018
Classification: Class II
Status: Terminated
Initiated: 2018-01-12
Posted: 2018-07-06
Terminated: 2020-07-22
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: BARD MYPICC Kit, REF CK000095B, 5F French Size, packaged 5 kits/case, Sterile, RX, For use in vascular access procedures.
Product code: OFF Central Venous Catheter Tray
Reason for recall: One of the cases of product might not have been sterilized.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The recalling firm's sales representative telephoned their one customer on 1/12/2018 requesting return of the product.
Quantity in commerce: 6/5-kit cases
Distribution: The product was distributed to UT.
Product codes and lots: Lot 17YM5936, Exp. 04/30/2019

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2378-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2378-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-18	2018-07-06

Product code OFF

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)