0.9% Sodium Chloride Injection, USP, pre-filled flush solution, for IV Flush only, sterile fluid path; 10 mL Single-Use

FDA device recall Z-0596-2012 · posted 2012-01-11 · Terminated

Recall details

Recalling firm

Hospira Inc.

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.

Action taken

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

Status

Terminated

Product code

NGT

Quantity affected

5,817,600 syringes

Distribution

Nationwide distribution including states of: Alabama, Alaska, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland

Date initiated

2011-11-18

Date posted

2012-01-11

Date terminated

2016-12-15

Location

Lake Forest, IL

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