AccuSure, U-100 28 Gauge, 1cc Insulin Syringe, 1/2" Needles, Short Needle, packaged 10 syringes per package, 10 packages per carton, NDC 0603-6996-21
FDA Recall Z-0570-2010 · Posted 2009-12-28
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Recall StatusTerminated
Product CodeFMF
Date Initiated2009-10-27
Date Terminated2010-11-24
Product Quantity398,075 cartons of 100
Reason for Recall
Needles are becoming dislodged from the barrels.
Firm Action
The 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 return the affected product. Questions are directed to the firm at telephone number 800-444-4011.
Root Cause
Other
Distribution Pattern
Nationwide
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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