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Terminated

Tyco HealthcareMonoject Prefill 10U/mL Heparin Lock Flush Syringe, 3mL REF # 8881580123, Tyco Healthcare, Mansfield, MA 02048

FDA Recall Z-1595-2008 · Posted 2008-05-09

Recalling FirmCovidien LP
Recall StatusTerminated
Product CodeNZW
Date Initiated2008-03-28
Date Terminated2012-06-25
Product Quantity262,800

Reason for Recall

Scientific Protein Laboratories (SPL), disclosed that two lots of Heparin Sodium, USP Active Pharmaceutical Ingredient has a heparin-like contaminant

Firm 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. .

Root Cause

Material/Component Contamination

Distribution Pattern

Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K032438MODIFICATION TO: MONOJET PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE, MONOJET PREFILL HEPRIN LOCK FLUSH SYRINGETyco Healthcare · 2004-06-30

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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