InviroSnap Retractable Safety Syringes, Rx Only, Single use, Sterile, Inviro Medical Devices, Inc., Duluth, GA 30096 USA
FDA device recall Z-1800-2010 · posted 2010-06-11 · Terminated
Recall details
- Recalling firm
- Inviro Medical Devices, Inc
- 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 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- MEG
- Quantity affected
- 623,000 units
- Distribution
- CA, FL, IL, MI, MO, MN, NC, OH, TX; and Canada
- Date initiated
- 2010-05-10
- Date posted
- 2010-06-11
- Date terminated
- 2011-12-08
- Location
- Lawrenceville, GA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SECUREGUARD RETRACTABLE SAFETY SYRINGE (K012121) | Safegard Medical Products, Inc. | 2001-10-24 |