Tyco Healthcare Monoject Prefill100U/mL Heparin Lock Flush Syringe 5mL REF # 8881590125, Tyco Healthcare, Mansfield, MA
FDA device recall Z-1601-2008 · posted 2008-05-09 · Terminated
Recall details
- Recalling firm
- Covidien LP
- Reason for recall
- Scientific Protein Laboratories (SPL), disclosed that two lots of Heparin Sodium, USP Active Pharmaceutical Ingredient has a heparin-like contaminant
- Action taken
- 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. .
- Root cause
- Material/Component Contamination
- Status
- Terminated
- Product code
- NZW
- Quantity affected
- 7,959,224 units
- Distribution
- Nationwide Distribution
- Date initiated
- 2008-03-28
- Date posted
- 2008-05-09
- Date terminated
- 2012-06-25
- Location
- Mansfield, MA
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