Tyco HealthcareMonoject Prefill 10U/mL Heparin Lock Flush Syringe, 3mL REF # 8881580123, Tyco Healthcare, Mansfield, MA 02048 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Tyco HealthcareMonoject Prefill 10U/mL Heparin Lock Flush Syringe, 3mL REF # 8881580123, Tyco Healthcare, Mansfield, MA 02048
Lot Codes / Batch Numbers
Lot Numbers: 7051524, 7113214
Products Sold
Lot Numbers: 7051524; 7113214
A medical device manufacturer is recalling Tyco HealthcareMonoject Prefill 10U/mL Heparin Lock Flush Syringe, 3mL REF # 8881580123, Tyco Health due to Scientific Protein Laboratories (SPL), disclosed that two lots of Heparin Sodium, USP Active Pharmaceutical Ingredient has a heparin-like contaminant. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Scientific Protein Laboratories (SPL), disclosed that two lots of Heparin Sodium, USP Active Pharmaceutical Ingredient has a heparin-like contaminant
Recommended Action
Per FDA guidance
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. .
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026