Z-1800-2010

InviroSnap Retractable Safety Syringes, Rx Only, Single use, Sterile, Inviro Medical Devices, Inc., Duluth...

Name: Z-1800-2010 InviroSnap Retractable Safety Syringes, Rx Only, Single use, Sterile, Inviro Medical Devices, Inc., Duluth...
Creator: Inviro Medical Devices, Inc
Published: 2010-05-10
License: https://open.fda.gov/license/

Inviro Medical Devices, Inc. / initiated 2010-05-10 / Terminated

FDA source

Inviro Medical Devices, Inc began a recall of InviroSnap Retractable Safety Syringes, Rx Only, Single use, Sterile, Inviro Medical Devices, Inc., Duluth, GA 30096 USA on 2010-05-10. The reason FDA records is "Syringe Defects. Group 1 syringes: The plunger pull out force was below specification. Group 2 syringes: The needle length is out of specification". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1800-2010
Status: Terminated
Initiated: 2010-05-10
Posted: 2010-06-11
Terminated: 2011-12-08
Recalling firm: Inviro Medical Devices, Inc.
Product: InviroSnap Retractable Safety Syringes, Rx Only, Single use, Sterile, Inviro Medical Devices, Inc., Duluth, GA 30096 USA.
Product code: MEG Syringe, Antistick
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 root cause: 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
Product codes and 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.

Product code MEG

K012121Class IISecureguard Retractable Safety SyringeSafegard Medical Products, Inc. / cleared 2001-10-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)