http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm307229.htm?source=govdelivery
PRODUCT
1) Monoject Insulin Safety Syringe 3/l0mL 29 X 1/2" Product ID: 8881511144 Indications for Use: Injection of U-1 00 insulin. Recall # Z-1694-2012;
2) Monoject Insulin Safety Syringe 3/10mL 30 X 5/16" Product ID: 8881511344 Indications for Use: Injection of U-1 00 insulin. Recall # Z-1695-2012;
3) Monoject Insulin Safety Syringe 1/2mL 29 X 1/2" Product ID: 8881511136 Indications for Use: Injection of U-1 00 insulin. Recall # Z-1696-2012;
4) Monoject Insulin Safety Syringe 1/2mL 30 X 5/16" Product ID: 8881511336 Indications for Use: Injection of U-1 00 insulin. Recall # Z-1697-2012
CODE
1) Lot Codes: 013816, 017007, 019113, 020608, 029905;
2) Lot Code: 019115;
3) Lot Code: Any lot in the series 015806-033106;
4) Lot Codes: 015605, 034606, 019114
RECALLING FIRM/MANUFACTURER
Recalling Firm: Covidien LLC, Mansfield MA, by letter dated May 21, 2012.
Manufacturer: Covidien, LP, Norfolk, NB. Firm initiated recall is ongoing.
REASON
Safety shield may separate from the syringe, exposing the needle, which could potentially result in a needle stick.
VOLUME OF PRODUCT IN COMMERCE
26,655,000 syringes
DISTRIBUTION
Nationwide, Canada, Australia, Belgium, and Panama
1) Monoject Insulin Safety Syringe 3/l0mL 29 X 1/2" Product ID: 8881511144 Indications for Use: Injection of U-1 00 insulin. Recall # Z-1694-2012;
2) Monoject Insulin Safety Syringe 3/10mL 30 X 5/16" Product ID: 8881511344 Indications for Use: Injection of U-1 00 insulin. Recall # Z-1695-2012;
3) Monoject Insulin Safety Syringe 1/2mL 29 X 1/2" Product ID: 8881511136 Indications for Use: Injection of U-1 00 insulin. Recall # Z-1696-2012;
4) Monoject Insulin Safety Syringe 1/2mL 30 X 5/16" Product ID: 8881511336 Indications for Use: Injection of U-1 00 insulin. Recall # Z-1697-2012
CODE
1) Lot Codes: 013816, 017007, 019113, 020608, 029905;
2) Lot Code: 019115;
3) Lot Code: Any lot in the series 015806-033106;
4) Lot Codes: 015605, 034606, 019114
RECALLING FIRM/MANUFACTURER
Recalling Firm: Covidien LLC, Mansfield MA, by letter dated May 21, 2012.
Manufacturer: Covidien, LP, Norfolk, NB. Firm initiated recall is ongoing.
REASON
Safety shield may separate from the syringe, exposing the needle, which could potentially result in a needle stick.
VOLUME OF PRODUCT IN COMMERCE
26,655,000 syringes
DISTRIBUTION
Nationwide, Canada, Australia, Belgium, and Panama