MONOJECT Prefill Heparin Lock Flush Syringe 10 Unit Heparin, 5 ml in 12 ml syringe Item code 8881580125
FDA device recall Z-0566-2011 · posted 2010-12-09 · Terminated
Recall details
- Recalling firm
- Covidien LP
- Reason for recall
- The heparin sodium USP used to manufacture was produced with crude heparin containing Over-Sulfated Chondroitin Sulfate.
- Action taken
- COVIDEN sent an URGENT PRODUCT RECALL letter dated November 12, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory and in-use stock to determine if they had any units of the affected product and quarantine the product immediately. Distributors were instructed to notify their customers immediately of the URGENT PRODUCT RECALL letter. Customers were to fill out the enclosed response form and return it by fax to (203) 822-6009 or email to adfeedback@coviden.com following the instructions on the form. For questions customers were to contact Customer Service at 1-800-962-9888
- Root cause
- Material/Component Contamination
- Status
- Terminated
- Product code
- NGT
- Quantity affected
- 1,356,480
- Distribution
- Nationwide Distribution including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, LA, KS, KY, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT
- Date initiated
- 2010-11-15
- Date posted
- 2010-12-09
- Date terminated
- 2015-12-04
- 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 |