Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 3 mL Fill Product ID: 8881580123 Product Usage: Both 0.9% So
FDA device recall Z-2182-2013 · posted 2013-09-10 · Terminated
Recall details
- Recalling firm
- Covidien LLC
- Reason for recall
- Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin
- Action taken
- Covidien sent an Urgent Medical Device Recall letter dated August 16, 2013 via Federal Express to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter requested that customers immediately quarantine and discontinue use of the affected products, return any affected product by following the instructions provided in the letter, and complete and return the Recalled Product Return Form to Covidien. The letter states that if the affected products have been distributed, assure that all customers are notified and affected product is removed from the distribution channel as well as from customer stock. Questions or concerns, please do not hesitate to contact your Covidien representative or Covidien Customer Service, Monday through Friday, 8am- 6:30pm ET, at (800) 962-9888, option 1, and then option 2. Firm issued Press on 8/19/13
- Root cause
- Process control
- Status
- Terminated
- Product code
- NGT
- Quantity affected
- Unknown
- Distribution
- Worldwide Distribution - USA Nationwide and the country of Bermuda
- Date initiated
- 2013-08-16
- Date posted
- 2013-09-10
- Date terminated
- 2015-10-21
- Location
- Mansfield, MA
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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 |