Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Hospira Latex-Free Blood Secondary Set, 26 Inch with Secure Lock; a sterile Rx tubing set for the administration of fluids from a blood bag in series with an I.V. solution bottle and I.V. set; Made in Costa Rica; Hospira, Inc., Lake Forest, IL 60045 USA; List No. 4602-58 For the administration of fluids from a blood bag in series with an I.V. solution bottle and I.V. set

FDA Recall Z-2024-2011 · Posted 2011-04-19

Recalling FirmHospira Inc.
Recall StatusTerminated
Product CodeKDC
Date Initiated2011-03-28
Date Terminated2012-05-09
Product Quantity28,608 sets

Reason for Recall

There is a potential for the air filter at the distal end of the set to become detached. This could result in the contamination of the sterile fluid path inside the tubing.

Firm Action

The firm, Hospira, sent an "URGENT DEVICE RECALL" letter dated March 28, 2011 to their customers. The letter described the product, problem and actions to be taken. The customers were instructed to check their inventory and immediately quarantine any affected product; complete and return the Reply Form via fax to 1-866-324-3734, even if you do not have the affected product; inform healthcare professionals in their organization of this recall; if they have distributed the product further, notify their accounts and have them fax the reply form to 1-866-324-3724; return the affected product to Stericycle using labels provided, and call Stericycle at 1-877-877-0481, if they have not received a return label. For medical inquiries, please call Hospira Medical Communications at 1-800-615-0187. Call Hospira Global Product Safety and Complaints at 1-800-441-4100 (8am-5pm CST, M-F) or by e-mail at ([email protected]).

Root Cause

Other

Distribution Pattern

Worldwide distribution: USA (nationwide) and countries including: Canada, Korea and Singapore.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑