AccuSure, U-100, 31Gauge, 1/2cc Insulin Syringe, 5/16" (8mm), Short Needle, NDC 0603-7001-21, packaged 10 syringes per package, 10 packages per carton
FDA Recall Z-2247-2009 · Posted 2009-09-24
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Recall StatusTerminated
Product CodeFMF
Date Initiated2009-08-21
Date Terminated2010-11-24
Product Quantity37,340 boxes of 100 units
Reason for Recall
Needles separate from the barrels of the syringes
Firm Action
The firm initiated the recall via a press release on 08/21/2009. They began notifying their consignees of the problem and the recall by letter on 08/21/2009. email: [email protected]
Root Cause
Nonconforming Material/Component
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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