Recall Z-1800-2010
Inviro Medical Devices, Inc · initiated May 10, 2010
Product
InviroSnap Retractable Safety Syringes, Rx Only, Single use, Sterile, Inviro Medical Devices, Inc., Duluth, GA 30096 USA.
Codes / lots: 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.
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: Other
Action taken
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.
Details
- Recall number
- Z-1800-2010
- Initiated
- May 10, 2010
- Posted by FDA
- June 11, 2010
- Terminated
- December 8, 2011
- Product code
- MEG – Syringe, Antistick
- Quantity
- 623,000 units
- Distribution
- CA, FL, IL, MI, MO, MN, NC, OH, TX; and Canada
- Recalling firm
- Inviro Medical Devices, Inc, Lawrenceville, GA