ClearanceBrief
Recall Z-0576-2010 ยท FMF Syringe, Piston

Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals

AccuSure, U-100 31 Gauge, 1cc Insulin Syringe, 5/16" (8mm) Needles, Short Needle, packaged 10 syringes per package, 10 packages per carton, NDC 0603-7002-21

DateDec 28, 2009 (initiated Oct 27, 2009)
StatusTerminated
ReasonNeedles are becoming dislodged from the barrels.
Root causeOther
ActionThe recall is being conducted to the Consumer level. A Press Release was issued on October 27, 2009 stating that Qualitest Pharmaceuticals was issuing a nationwide recall of all Accusure Insulin Syringes. The consignees were asked to post a copy of the press release in their retail stores and to alert patients of this action. Also, Recall Notifications were sent to all of the firm's consignees by First Class Mail on October 30, 2009. The consignees were instructed to notify their customers or sub accounts who may have been sold or dispensed the affected syringes starting in 2002, and to retu
Quantity97,045 cartons of 100
DistributionNationwide
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K021197SUREONE INSULIN SYRINGE, 31 GAUGE X 5/16
Hosuk Co., Ltd., Apr 26, 2002
K080904FEEL-FINE INSULIN PEN NEEDLE
Feel Tech, Jun 4, 2008