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U.S. Department of Health and Human Services

Class 3 Device Recall PERFEKTUM

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 Class 3 Recall
PERFEKTUM
see related information
Date Posted February 12, 2008
Recall Status1 Terminated on May 12, 2008
Recall Number Z-0881-2008
Recall Event ID 46322
Product Classification Needle, Hypodermic, Single Lumen - Product Code FMI
Product PERFEKTUM TOOMEY EVACUATING SYRINGES, REF/Part # 5047, DESCRIPTION: 30CC LOCK TIP, RX ONLY, NON-STERILE. Manufactured By: Popper & Sons, Inc. New Hyde Park, NY. 11040.
Code Information Lot Number: B/503726-907-2
Recalling Firm/
Manufacturer
Popper & Sons Inc
300 Denton Avenue
New Hyde Park, New York 11040-3437
For Additional Information Contact Mr. Ira L. Zuckerman
516-248-0300 Ext. 226
Manufacturer Reason
for Recall
Mis-labeling: the product name on the label was erroneously declared as PERFECTUM TOOMEY EVACUATING SYRINGES instead of POPPER INTERCHANGEABLE HYPODERMIC SYRINGES for one lot of the product. Note: the product information (part number, description, lot number) found in the white box portion of the label is listed correctly.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action The recalling firm, Popper & Sons, began contacting its customers by telephone on/about 1/02/08, informing them of the issue. This was followed up with formal recall letters, Urgent Recall, and response forms starting on 1/09/08 via Certified Mail, Return Receipt Requested to the US accounts, and Registered Mail to the two Canadian accounts. The firm has directed the customers to discontinue using or distributing the lot and return any remaining quantity of this lot of syringes. If the lot has been further distributed, the distributors were instructed to immediately contact their accounts, advise them of the recall situation and have them return their outstanding recall stock as indicated above.
Quantity in Commerce Domestic - 259 units; Canada - 13 units
Distribution Worldwide-USA including the states of NY, NJ, PA, MI, IL, OH, FL, MO, TX, and CA, and country of Canada
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.
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