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U.S. Department of Health and Human Services

Class 2 Device Recall InviroSnap

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  Class 2 Device Recall InviroSnap see related information
Date Initiated by Firm May 10, 2010
Date Posted June 11, 2010
Recall Status1 Terminated 3 on December 08, 2011
Recall Number Z-1800-2010
Recall Event ID 55674
510(K)Number K012121  
Product Classification Syringe, antistick - Product Code MEG
Product InviroSnap¿ Retractable Safety Syringes, Rx Only, Single use, Sterile, Inviro Medical Devices, Inc., Duluth, GA 30096 USA.
Code Information Group #1: Catalog number: 100002, Lot number: 2006-06; Catalog number: 100017, Lot number: 2006-09, Catalog number: 100018, Lot number: 2006-06 and 2006-08; Catalog number: 100019, Lot number: 2006-06, 2006-08, 2006-09 and 2006-10; Catalog number: 100032, Lot number 2006-07 and Catalog number: 100034, Lot number; 2006-10.   Group #2: Catalog number: 100019, Lot number: 2006-17, 061904, 062909, 063704 and 063804; Catalog number: 100032, Lot number: 2006-07 and 2006-08; Catalog number: 100038; Lot number: 061911, 062711 and 062811; Catalog number: 100047, Lot number: 2006-06, 2006-07 and 2006-15; Catalog number: 100055, Lot number: 062415. 
Recalling Firm/
Manufacturer		 Inviro Medical Devices, Inc
1755 N Brown Rd Ste 150
Lawrenceville GA 30043-8194
For Additional Information Contact James Barley
949-433-3058
Manufacturer Reason
for Recall		 Syringe Defects. Group 1 syringes: The plunger pull out force was below specification. Group 2 syringes: The needle length is out of specification.
FDA Determined
Cause 2		 Other
Action Consignees were notified by letter on or about 05/10/2010. Consignees were instructed to review their inventory of InviroSnap Safety Syringes for the lot numbers and remove them from inventory and to return the affected product to Inviro Medical. They were instructed to pass on the information to anyone who uses or orders Inviro Snap Safety Syringes at their facility and to ensure a copy of the letter is provided to any other organizations to which affected devices have been transferred. A Response Card was included to be completed and faxed back to Inviro Medical Devices even if there is no product in inventory to verify receipt of notification. Questions regarding the recall were directed to the company's Customer Service number at (866) 914-2259. All product from Group 1 will be scrapped. Product from Group 2 will be retained in Quarantine until such time as the product can be exported the permission of the importing countries Ministry of Health.
Quantity in Commerce 623,000 units
Distribution CA, FL, IL, MI, MO, MN, NC, OH, TX; and Canada
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 = MEG and Original Applicant = SAFEGARD MEDICAL PRODUCTS, INC.
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