Z-0936-03

Abbott Latex-Free Primary I.V. Plumset Convertible Pin, 95 inch with Injection Site and Secure Lock, No...

Name: Z-0936-03 Abbott Latex-Free Primary I.V. Plumset Convertible Pin, 95 inch with Injection Site and Secure Lock, No...
Creator: Abbott Laboratories HPD/ADD
Published: 2003-05-13
License: https://open.fda.gov/license/

Abbott Medical / initiated 2003-05-13 / Terminated

FDA source

Abbott Laboratories HPD/ADD began a recall of Abbott Latex-Free Primary I.V. Plumset Convertible Pin, 95 inch with Injection Site and Secure Lock, No. 19020; Made in Costa Rica, Abbott Laboratories, North... on 2003-05-13. The reason FDA records is "The I.V. administration set incorrectly lists the priming volume from the cassette inlet to distal male adapter as 13.5 mL instead of 11.3 mL". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0936-03
Status: Terminated
Initiated: 2003-05-13
Posted: 2003-06-17
Terminated: 2003-11-20
Recalling firm: Abbott Medical
Product: Abbott Latex-Free Primary I.V. Plumset Convertible Pin, 95 inch with Injection Site and Secure Lock, No. 19020; Made in Costa Rica, Abbott Laboratories, North Chicago, IL 60064
Product code: FPA Set, Administration, Intravascular
Reason for recall: The I.V. administration set incorrectly lists the priming volume from the cassette inlet to distal male adapter as 13.5 mL instead of 11.3 mL
FDA root cause: Other
Action: Recall letter dated 5/12/03 sent to the account on 5/13/03, informing them of the labeling discrepancy and requesting the return of any inventory of the affected lot to Abbott for credit.
Quantity in commerce: 4,656 units
Distribution: Miami, FL
Product codes and lots: List number 19020-04-12, lot 941845H

Product code FPA

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)