Z-1353-2010

Lifeshield, latex-free, Primary I.V. Pump Set with Distal Microbore Patient Line, convertible pin, 110 inch...

Name: Z-1353-2010 Lifeshield, latex-free, Primary I.V. Pump Set with Distal Microbore Patient Line, convertible pin, 110 inch...
Creator: Hospira Inc.
Published: 2009-11-24
License: https://open.fda.gov/license/

Abbott Medical / initiated 2009-11-24 / Terminated / root cause: design

FDA source

Hospira Inc. began a recall of Lifeshield, latex-free, Primary I.V. Pump Set with Distal Microbore Patient Line, convertible pin, 110 inch with inline cassette, collection bag, pre-pierced... on 2009-11-24. The reason FDA records is "Reports of difficulty in adjusting the flow rate, which could result in flow rate variances". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1353-2010
Status: Terminated
Initiated: 2009-11-24
Posted: 2010-04-15
Terminated: 2012-01-29
Recalling firm: Abbott Medical
Product: Lifeshield, latex-free, Primary I.V. Pump Set with Distal Microbore Patient Line, convertible pin, 110 inch with inline cassette, collection bag, pre-pierced injection site and OPTION-LOK for use with OMNI-FLOW medication management system, 15 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Forest, IL USA. Made in Costa Rica, list 1169-02.
Product code: FPA Set, Administration, Intravascular
Reason for recall: Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.
Root cause tag: design
FDA root cause: Component design/selection
Action: Hospira sent the Urgent Device Recall letters dated 11/25/09 to their direct accounts of the affected products and requested these consignees to notify their customers of the recall. The accounts were informed that Hospira ceased manufacturing the I.V. gravity and pump administration sets with the CAIR clamp manufactured by Borla S.P.A. of Italy in March 2008, due to customer reports related to a difference in the zone of control used to adjust the flow compared to the original CAIR clamp design. To avoid the possibility of flow rate variances, Hospira is recalling all remaining sets with the Borla designed CAIR clamp. The accounts were requested to quarantine all inventory of the affected lots, complete the enclosed reply form indicating the amount of product being returned, fax a copy of the completed form to Stericycle at 1-877-377-5114, and include a copy with the returned goods to Stericycle at 2670 Executive Drive, Suite A, Indianapolis, IN 46241.
Quantity in commerce: 52,656 sets
Distribution: Worldwide Distribution -- U.S., Puerto Rico, Dominican Republic, Bahamas, Virgin Islands, Argentina, Australia, Bahrain, Belgium, Canada, China, Denmark, Ecuador, EI Salvador, Finland, France, Germany, Greece, Guatemala, Hong Kong, Ireland, Italy, Jordan, Kuwait, Lebanon, Libya, Mexico, Netherlands, New Zealand, Nicaragua, Norway, Oman, Panama, Peru, Philippines, Poland, Portugal, San Marino, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Uruguay, and United Arab Emirates.
Product codes and lots: Lot numbers: 520655H, 530665H, 560565H, 591215H, 591285H, 591735H, and 591745H.

Product code FPA

K832755Class IIInfusion Pump & IV Sets #4000Omni-Glow, Inc. / cleared 1983-11-03

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)