AccuSure, U-100 31 Gauge, 1cc Insulin Syringe, 5/16" (8mm) Needles, Short Needle, packaged 10 syringes per package, 10 packages per carton, NDC 0603-7002-2
FDA Recall Z-1504-2009 · Posted 2009-06-24
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Recall StatusTerminated
Product CodeFMF
Date Initiated2009-04-09
Date Terminated2010-11-01
Product Quantity559,500 syringes
Reason for Recall
Needles separate from the barrel of the syringes.
Firm Action
On 04/09/2009, Qualitest issued a press release and sent out recall notifications to their consignees by US Mail. The recall was extended to the User level. Qualitest will send a second letter to all non-responders after thirty days. Thirty days after the second letter, Qualitest will perform a recall effectiveness check by telephone on a percentage of non-responders (in accordance with FDA request).
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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