Hospira Inc.: 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

Recall number

Z-0596-2012

Recalling firm

Hospira Inc.

Product

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

Status

Terminated

Initiated

2011-11-18

Posted

2012-01-11

Terminated

2016-12-15

Reason

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

Root cause

Material/Component Contamination

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.

Quantity

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, 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.

Lot, serial or model codes

List Number 1078-20, lots 91-100-5E, 91-102-5E, 91-106-5E, 91-114-5E, 91-116-5E and 91-118-5E.  The recall was expanded to include the following additional lot numbers: 92-131-5E, 92-133-5E, 93-211-5E, 93-229-5E, 93-230-5E, 93-232-5E, 94-224-5E, 94-230-5E, 94-233-5E, 95-182-5E, 01-168-5E, 01-170-5E and 02-157-5E.

510(k) numbers

["K090882"]

PMA numbers

not on file

Product code

NGT

Firm FEI

3013319212

Firm city

Lake Forest

Firm state

IL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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