Recall Z-1602-2008 ยท NZW Heparin, Vascular Access Flush
Covidien LP
Tyco Healthcare Monoject Prefill 100UlmL Heparin Lock Flush Syringe 5mL, with BLUNTIP plastic cannula REF # 8881591125, Tyco Healthcare, Mansfield, MA 02048
| Date | May 9, 2008 (initiated Mar 28, 2008) |
| Status | Terminated |
| Reason | Scientific Protein Laboratories (SPL), disclosed that two lots of Heparin Sodium, USP Active Pharmaceutical Ingredient has a heparin-like contaminant |
| Root cause | Material/Component Contamination |
| Action | Tyco Healthcar notifed customers by letter sent via US Postal Service beginning 3/28/08, through 4/1/08. The letter requests that they immediately stop using and return the product. Distributors are requested to in-turn notify their customers. An instruction sheet was attached for product return and replacement. All customers are required to respond to the notice regardless of remaining inventory. . |
| Quantity | 21,600 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032438 | MODIFICATION TO: MONOJET PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE, MONOJET PREFILL HEPRIN LOCK FLUSH SYRINGE Tyco Healthcare, Jun 30, 2004 |