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Terminated

InviroSnap Retractable Safety Syringes, Rx Only, Single use, Sterile, Inviro Medical Devices, Inc., Duluth, GA 30096 USA.

FDA Recall Z-1800-2010 · Posted 2010-06-11

Recall StatusTerminated
Product CodeMEG
Date Initiated2010-05-10
Date Terminated2011-12-08
Product Quantity623,000 units

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.

Firm 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.

Root Cause

Other

Distribution Pattern

CA, FL, IL, MI, MO, MN, NC, OH, TX; and Canada

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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