FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corp.: Y-Type Blood/Solution Set with Pressure Pump, catalog #1C8658; Standard Blood Filter (170 to 260 micron), Drip Chamber Pump, Injection Site, Male Luer Lock Adapter, 109'' long, 10 drops per mL; Baxter Healthcare Corporation, Deerfield, IL 60015
- Recall number
- Z-0452-03
- Recalling firm
- Baxter Healthcare Corp.
- Product
- Y-Type Blood/Solution Set with Pressure Pump, catalog #1C8658; Standard Blood Filter (170 to 260 micron), Drip Chamber Pump, Injection Site, Male Luer Lock Adapter, 109'' long, 10 drops per mL; Baxter Healthcare Corporation, Deerfield, IL 60015
- Status
- Terminated
- Initiated
- 2002-12-18
- Posted
- 2003-01-16
- Terminated
- 2003-09-30
- Reason
- Leakage may occur at the inlet port
- Root cause
- Other
- Action
- The affected product codes and lot numbers were recalled by letter dated 12/18/02. The customers were informed of the potential leakage at the inlet port, and were requested to inspect their inventory for the affected products and destroy those found. The accounts were requested to complete the enclosed reply form and certificate of destruction and return them to Baxter for credit issuance.
- Quantity
- 1,392 sets
- Distribution
- Nationwide
- Lot, serial or model codes
- GR184184, GR186551
- 510(k) numbers
- ["K881321"]
- PMA numbers
- not on file
- Product code
- KSB
- 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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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