100 U/mL Heparin Lock Flush Solution USP; Baxter Healthcare Corporation, Deerfield, IL 60015; 30 syringes per case
FDA device recall Z-0458-03 · posted 2003-01-23 · Terminated
Recall details
- Recalling firm
- Baxter Healthcare Corp.
- Reason for recall
- Sterility questioned
- Action taken
- Recalled by letter dated 12/12/02. Customers were informed of the compromised sterility of all lots of the listed products within expiration date, and were requested to destroy all lot numbers of the identified product codes. Baxter will issue their customers credit for the product destroyed.
- Root cause
- Other
- Status
- Terminated
- Product code
- FOZ
- Quantity affected
- 727,560 syringes
- Distribution
- Nationwide, Canada, Honduras, Indonesia, Israel
- Date initiated
- 2002-12-12
- Date posted
- 2003-01-23
- Date terminated
- 2004-06-29
- Location
- Round Lake, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HEPARIN LOCK FLUSH SYRING 10 USP UNITS/ML, HEPARIN LOCK FLUSH SYRINGE, 100 USP UNITS/ML (K003245) | Baxter Healthcare Corp | 2000-12-04 |