Covidien recalls 32 lots of syringes containing Heparin

Company?s recall follows Baxter?s six-country Heparin recall

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  • Covidien
  • Pre-filled syringes containing heparin sodium USP

On March 28, 2008, Covidien recalled 32 lots of pre-filled syringes containing heparin sodium USP active pharmaceutical ingredient because there could be potential for a bacterial infection. Covidien?s heparin recall was in response to a notification from Scientific Protein Laboratories (SPL), the company that supplies both Baxter Healthcare and Covidien with the active pharmaceutical ingredient used to make heparin.

Covidien, which was formerly Tyco Healthcare, said no adverse events have been associated with its products. Baxter has reported 785 adverse events with its heparin product, including at least 19 deaths.

Sources: ?Covidien initiates voluntary recall of pre-filled syringes containing heparin,? US Food and Drug Administration Press Release, March 28, 2008; Peggy Peck, ?More heparin recalled because of contamination,? MedPage Today, April 2, 2008 (http://www.medpagetoday.com/ProductAlert/Prescriptions/tb/8996).

The following are the product descriptions and lot numbers for the products included in the Covidien heparin recall:

Product Lot Numbers
REF # 8881580121 7082274
Monoject PreFillTM 10U/mL Heparin 7113214
Lock Flush Syringe, 10mL
REF # 8881580123 7051524
Monoject PreFillTM 10U/mL Heparin 7113214
Lock Flush Syringe, 3mL
REF # 8881580125 7051524
Monoject PreFillTM 10U/mL Heparin 7082274
Lock Flush Syringe 5mL 7113164
7113174
REF # 8881580300 7051444
Monoject PreFillTM 10U/mL Heparin
Lock Flush Syringe
2.5mL in 3mL syringe
REF # 8881581125 7082274
Monoject PreFillTM 10U/mL Heparin
Lock Flush Syringe 5mL, with BLUNTIP plastic cannula
REF # 8881590121 7113064
Monoject PreFillTM 100U/mL Heparin
Lock Flush Syringe 10mL
7041194
REF # 8881590123 7072154
Monoject PreFillTM 100U/mL Heparin 7113034
Lock Flush Syringe 3mL 8010194
REF # 8881591125 7082284
Monoject PreFillTM 100U/mL Heparin
Lock Flush Syringe 5mL, with BLUNTIP plastic cannula
REF # 8881590125 7041194
Monoject PreFillTM 100U/mL Heparin 7102804
Lock Flush Syringe 5mL 7041204
7113034
7051534
7113044
7051544
7113054
7051554
7113104
7071924
7113114
7072034
7113154
7072044
8010064
7072054
8010114
7072064
8010134
7072154
8010174
7082284
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