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U.S. Department of Health and Human Services

Class 2 Device Recall Monoject Insulin Safety Syringe 3/l0mL 29 X 1/2"

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  Class 2 Device Recall Monoject Insulin Safety Syringe 3/l0mL 29 X 1/2" see related information
Date Initiated by Firm May 21, 2012
Date Posted May 31, 2012
Recall Status1 Terminated 3 on June 10, 2013
Recall Number Z-1694-2012
Recall Event ID 61908
510(K)Number K922522  
Product Classification Syringe, piston - Product Code FMF
Product Monoject Insulin Safety Syringe 3/l0mL 29 X 1/2"
Product ID: 8881511144

Indications for Use: Injection of U-1 00 insulin
Code Information Lot Codes:  013816, 017007, 019113, 020608, 029905
Recalling Firm/
Manufacturer		 Covidien LLC
15 Hampshire Street
Mansfield MA 02048-1113
For Additional Information Contact
508-261-8000
Manufacturer Reason
for Recall		 Safety shield may separate from the syringe, exposing the needle, which could potentially result in a needle stick
FDA Determined
Cause 2		 Equipment maintenance
Action Covidien sent an Urgent Product Recall letter dated May 21, 2012, via Federal Express. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately stop using any affected product. Distributors were requested to notify their customers. Customers were instructed to complete the Monoject Insulin Safety Syringe recalled product return form even if they have no product to return. The form should be faxed to 1-800-895-6140 or e-mailed to sdfeedback@covidien.com. Customer Service questions regarding the recall please use one of the following methods. Telephone:1-800-722-8772 option I (Weekdays, 8am to 6:30pm Eastern) e-mail:sdfeedback@covidien.com
Quantity in Commerce 952,000 syringes
Distribution Worldwide Distribution - USA (nationwide) and the countries of Canada, Australia, Belgium, and Panama.
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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