Z-1491-2012

LifeShield Primary Plumset, CLAVE port, CLAVE Y-Site, 104 inch, 15 drops/mL, 48 sets per case; a sterile Rx...

Name: Z-1491-2012 LifeShield Primary Plumset, CLAVE port, CLAVE Y-Site, 104 inch, 15 drops/mL, 48 sets per case; a sterile Rx...
Creator: Hospira Inc.
Published: 2012-04-25
License: https://open.fda.gov/license/

Abbott Medical / initiated 2012-04-25 / Terminated / root cause: manufacturing process

FDA source

Hospira Inc. began a recall of LifeShield Primary Plumset, CLAVE port, CLAVE Y-Site, 104 inch, 15 drops/mL, 48 sets per case; a sterile Rx device; Hospira Inc, Lake Forest, IL USA. Made in... on 2012-04-25. The reason FDA records is "The Lifeshield Primary Plumsets may cause a cassette test failure alarm when the set is loaded onto the infusion pump. A set which results in a cassette test failure alarm may result in delay in therapy, requiring...". 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-1491-2012
Status: Terminated
Initiated: 2012-04-25
Posted: 2012-05-04
Terminated: 2016-12-15
Recalling firm: Abbott Medical
Product: LifeShield Primary Plumset, CLAVE port, CLAVE Y-Site, 104 inch, 15 drops/mL, 48 sets per case; a sterile Rx device; Hospira Inc, Lake Forest, IL USA. Made in Costa Rica; product 120300412, list number 12030-12. Product Usage: For administration of I.V. fluids.
Product code: FRN Pump, Infusion
Reason for recall: The Lifeshield Primary Plumsets may cause a cassette test failure alarm when the set is loaded onto the infusion pump. A set which results in a cassette test failure alarm may result in delay in therapy, requiring medical intervention.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Hospira, sent an "URGENT DEVICE RECALL" letter dated April 25, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The customers were instructed to check their inventory and immediately quarantine any affected product to return for credit. A Reply Form was enclosed for customers to complete and return via fax to 1-888-386-2073 or e-mail to: [email protected]. Contact Hospira Customer Care at 1-877-946-7747 for information regarding product availability.
Quantity in commerce: 145,875 sets
Distribution: Worldwide Distribution - USA (nationwide) including the states of: Alabama, Colorado, Georgia, Illinois, Indiana, Iowa, Kentucky, Maryland, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Oklahoma, Pennsylvania, Wisconsin and the country of Australia.
Product codes and lots: list number 12030-12; lot number 89-029-5H; expiration date 01 JUN 2013

Product code FRN

K865060Class IIi.v. Set with Dual-Channel CassetteAbbott Laboratories / cleared 1987-02-06

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)