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
This recall has been terminated (originally issued June 24, 2009).
- Recall Initiated
- April 9, 2009
- Posted
- June 24, 2009
- Terminated
- November 1, 2010
- Recall Number
- Z-1504-2009
- Quantity
- 559,500 syringes
- Firm Location
- Huntsville, AL
- Official Source
- View on FDA website ↗
Reason for Recall
Needles separate from the barrel of the syringes.
Distribution
Nationwide.
Lot / Code Info
Lot A07001, exp 07/2012
Root Cause
Nonconforming Material/Component
Action Taken
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).
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