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U.S. Department of Health and Human Services

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 Class 2 Recall
InviroSnap		see related information
Date Posted June 11, 2010
Recall Number Z-1800-2010
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, Georgia 30043-8194
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact James Barley
949-433-3058
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.
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
 
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