FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corp.: 100 U/mL Heparin Lock Flush Solution USP; Baxter Healthcare Corporation, Deerfield, IL 60015; 30 syringes per case
- Recall number
- Z-0458-03
- Recalling firm
- Baxter Healthcare Corp.
- Product
- 100 U/mL Heparin Lock Flush Solution USP; Baxter Healthcare Corporation, Deerfield, IL 60015; 30 syringes per case
- Status
- Terminated
- Initiated
- 2002-12-12
- Posted
- 2003-01-23
- Terminated
- 2004-06-29
- Reason
- Sterility questioned
- Root cause
- Other
- Action
- 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.
- Quantity
- 727,560 syringes
- Distribution
- Nationwide, Canada, Honduras, Indonesia, Israel
- Lot, serial or model codes
- all lots within expiration date of the following pre-filled syringes: Code 2K6049: 3 mL in 12 mL syringe Code 2K6050: 5 mL in 12 mL syringe Code 2K6058: 5 mL in 12 mL syringe w/cannula
- 510(k) numbers
- ["K003245"]
- PMA numbers
- not on file
- Product code
- FOZ
- Firm FEI
- 1416980
- Firm city
- Round Lake
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28