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U.S. Department of Health and Human Services

Class 2 Device Recall Kendall Monoject

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  Class 2 Device Recall Kendall Monoject see related information
Date Initiated by Firm September 11, 2006
Date Posted October 21, 2006
Recall Status1 Terminated 3 on September 11, 2009
Recall Number Z-0051-2007
Recall Event ID 36299
510(K)Number K852544  
Product Classification Monoject Syringe with Hypodermic Needle, - Product Code FMF
Product Kendall Monoject Syringe with Hypodermic Needle, 3cc syringe with 27 ga A-Bevel Needle (3cc- 27x1-1/4 A) Product # 8881513744
Code Information Lot Numbers: 611406 and 611407
Recalling Firm/
Manufacturer		 Kendall a Division of Tyco Healthcare Group LP
5439 State Route 40
Argyle NY 12809-3830
Manufacturer Reason
for Recall		 Incorrect needle: There is an incorrect needle configuration on the syringe. The correct needle has a 27 gage A-bevel, the needle on the syringe has no bevel, typically used for dental irrigation.
FDA Determined
Cause 2		 Other
Action A recall letter was mailed 9/12/2006 to the 44 customers who purchased this product from Tyco Healthcare. The firm requested that their distributors notify their customers, and coordinate recovery of the product. The recall mailing included a form that was to be faxed back to Tyco Healthcare. A postage paid return envelope was also included if the customer does not have access to a fax machine.
Quantity in Commerce 130,000
Distribution Nationwide
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FMF and Original Applicant = SHERWOOD MEDICAL CO.
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