Tyco Healthcare Monoject Prefill 10U/mL Heparin Lock Flush Syringe 5mL, with BLUNTIP plastic cannula REF # 8881581125, T
FDA device recall Z-1598-2008 · 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
- 6,300 units
- Distribution
- Nationwide Distribution
- Date initiated
- 2008-03-28
- Date posted
- 2008-05-09
- Date terminated
- 2012-06-25
- Location
- Mansfield, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO: MONOJET PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE, MONOJET PREFILL HEPRIN LOCK FLUSH SYRINGE (K032438) | Tyco Healthcare | 2004-06-30 |