Recall Z-1800-2010 ยท MEG Syringe, Antistick
Inviro Medical Devices, Inc
InviroSnap Retractable Safety Syringes, Rx Only, Single use, Sterile, Inviro Medical Devices, Inc., Duluth, GA 30096 USA.
| Date | Jun 11, 2010 (initiated May 10, 2010) |
| Status | Terminated |
| Reason | Syringe Defects. Group 1 syringes: The plunger pull out force was below specification. Group 2 syringes: The needle length is out of specification. |
| 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 p |
| Quantity | 623,000 units |
| Distribution | CA, FL, IL, MI, MO, MN, NC, OH, TX; and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012121 | SECUREGUARD RETRACTABLE SAFETY SYRINGE Safegard Medical Products, Inc., Oct 24, 2001 |