Heparin Lock Flush Solution 100 Unit/mL, USP 3 ml, 4 ml, 5mL, 6 ml fill in a 10 ml Flush Syringe ZR Excelsior Medical Ne
FDA device recall Z-1707-2012 · posted 2012-06-05 · Terminated
Recall details
- Recalling firm
- Excelsior Medical Corp
- Reason for recall
- Some lots of Heparin Lock Flush, USP Syringes (3 mL fill in 10 ml syringe, 4 mL fill in 10 ml syringe, 5 mL fill in 10 ml and 6 ml in 10 ml syringe), failed Anti-Factor IIa assay for potency.
- Action taken
- Excelsior Medical sent an "URGENT MEDICAL DEVICE RECALL" letter dated May 4, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to discontinue using the affected product and to complete and return an attached Customer Reply Form via fax to (866) 807-3714. Contact Excelsior Medical Customer Service at (800) 487-4276 for questions regarding this recall. A second letter which included additional lots was sent out on 5/25/2012 with the date of 5/24/2012. A return response form was also included.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- NZW
- Quantity affected
- 34,230,500 units (596 lots)
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Brazil, Canada, and Colombia.
- Date initiated
- 2012-05-07
- Date posted
- 2012-06-05
- Date terminated
- 2013-09-12
- Location
- Neptune, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYREX HEPARIN LOCK FLUSH SYRINGE, 1 UNIT/ML & 2 UNITS/ML (K061497) | Excelsior Medical Corp. | 2007-02-23 |