—#105642

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

FDA product code: NGT — Saline, Vascular Access Flush
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K090882
Affected lot / code info: 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.

Why it was recalled

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 (FDA determination)

Material/Component Contamination

Action the firm took

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.

Recalling firm

Firm: Hospira Inc.
Address: 275 N Field Dr, Lake Forest, Illinois 60045-2579

Distribution

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.

Timeline

Recall initiated: 2011-11-18
Posted by FDA: 2012-01-11
Terminated: 2016-12-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #105642. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.