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U.S. Department of Health and Human Services

Class 2 Device Recall 0.9 Sodium Chloride Flush Syringe

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 Class 2 Recall
0.9 Sodium Chloride Flush Syringe
see related information
Date Posted January 11, 2012
Recall Status1 Open
Recall Number Z-0596-2012
Recall Event ID 60504
Premarket Notification
510(K) Number
K090882 
Product Classification Saline, Vascular Access Flush - Product Code NGT
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
Code Information 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.
Recalling Firm/
Manufacturer
Hospira Inc.
275 N Field Dr
Lake Forest, Illinois 60045-2579
For Additional Information Contact Ms. Ileana Quinones
224-212-2000
Manufacturer 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.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): 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 in Commerce 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = NGT and Original Applicant = HOSPIRA, INC.
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