Z-0195-06

LifeShield Latex-Free HEMA Blood PlumSet, Nonvented, 110 Inch with 210 Micron Filter, Prepierced Injection...

Name: Z-0195-06 LifeShield Latex-Free HEMA Blood PlumSet, Nonvented, 110 Inch with 210 Micron Filter, Prepierced Injection...
Creator: Hospira Inc.
Published: 2005-05-06
License: https://open.fda.gov/license/

Abbott Medical / initiated 2005-05-06 / Terminated

FDA source

Hospira Inc. began a recall of LifeShield Latex-Free HEMA Blood PlumSet, Nonvented, 110 Inch with 210 Micron Filter, Prepierced Injection Site and OPTION-LOK, Dual Channel, Capped Secondary... on 2005-05-06. The reason FDA records is "Inlet and outlet tubing on the cassette may be reversed, which would result in reverse flow". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0195-06
Status: Terminated
Initiated: 2005-05-06
Posted: 2005-11-24
Terminated: 2005-11-29
Recalling firm: Abbott Medical
Product: LifeShield Latex-Free HEMA Blood PlumSet, Nonvented, 110 Inch with 210 Micron Filter, Prepierced Injection Site and OPTION-LOK, Dual Channel, Capped Secondary Port; a sterile Rx blood administration set for use with the Plum Series Infuser; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; list number 11235-03
Product code: BRZ Set, Blood Transfusion
Reason for recall: Inlet and outlet tubing on the cassette may be reversed, which would result in reverse flow.
FDA root cause: Other
Action: Hospira sent product recall letters dated 5/6/05 to the accounts via Federal Express overnight letter on the same date. The letters informed the accounts of the possiblitiy of the inlet and outlet tubing being reversed on the cassette, which would allow the patient''s blood to be drawn up the tubing. The accounts were requested to examine their inventory for the affected lot, quarantine any found and call Hospira Customer Care at 1-877-946-7747 to arrange for return of the product for replacement.
Quantity in commerce: 17,184 units
Distribution: Nationwide including Puerto Rico, and internationally to Mexico and Australia
Product codes and lots: lot 25-086-5H

Product code BRZ

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)