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Terminated

0.9% Sodium Chloride Injection, USP, pre-filled flush solution, for IV Flush only, sterile fluid path; 10 mL Single-Use Syringe with Male Luer Lock, 100 syringes per pack, 4 packs per case; Made in Costa Rica, Hospira, Inc., Lake Forest, IL 60045 USA; list no. 1978-20 lock flush solution

FDA Recall Z-0596-2012 · Posted 2012-01-11

Recalling FirmHospira Inc.
Recall StatusTerminated
Product CodeNGT
Date Initiated2011-11-18
Date Terminated2016-12-15
Product Quantity5,817,600 syringes

Reason for Recall

There is particulate matter in the fluid pathway, which has been identified as the same material as the rubber tip of the syringe plunger.

Firm Action

Hospira sent a "URGENT DEVICE RECALL" letter dated November 18, 2011, to all affected customers via UPS. The letter identified the product the problem and the action needed to be taken by the customer. The customers were instructed to check their inventory and immediately quarantine any affected product complete and return Reply Form via fax to 1-866-912-2512. Return affected product to Stericycle using the label provided with the letter and if they have distributed the product further, notify their accounts that received the product . Please contact Hospira Customer Care at 1-877-946-7747 or your Hospira representative for information regarding product availability. Hospira expanded the recall to include thirteen additional affected lots via letter dated January 31, 2012. The recall instructions remain the same as in the November 18,2011 letter.

Root Cause

Material/Component Contamination

Distribution Pattern

Nationwide distribution including states of: Alabama, Alaska, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Mississippi, Missouri, Nebraska, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia and Wisconsin.

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.

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