Recall Z-1229-2025— CareFusion 303, Inc.
Class II · Ongoing
Class II FDA medical device recall by CareFusion 303, Inc., initiated 2025-01-08. FDA's recall record names no specific 510(k) clearance for this event. Product: 139054-01 BD PYXIS MEDFLEX MN 1000 10HH-1FM 139055-01 BD PYXIS MEDFLEX MN 1000 12HH 139053-01 BD PYXIS MEDFLEX MN 1000 2HH-2FH-3FM 139041-01 BD PYXIS MEDFLEX MN 1000 2HH-2FM 139046-01 BD PYXIS MEDFLEX MN 1000 2HH-5FM 139038-01 BD PYXIS MEDFLEX MN 1000 3FM 139040-01 BD PYXIS MEDFLEX MN 1000 4HH-1FM 139049-01 BD PYXIS MEDFLEX MN 1000 4HH-4FM 139044-01 BD PYXIS MEDFLEX MN 1000 6FM 139039-01 BD PYXIS MEDFLEX MN 1000 6HH 139051-01 BD PYXIS MEDFLEX MN 1000 6HH-3FM 139164-01 BD PYXIS MEDFLEX MN 1000 8HH-2FH 139052-01 BD PYXIS MEDFLEX MN 1000 8HH-2FM 139070-01 BD PYXIS MEDFLEX MN 2000 10HH-1FM 139071-01 BD PYXIS MEDFLEX MN 2000 12HH 139061-01 BD PYXIS MEDFLEX MN 2000 2HH-2FM 139066-01 BD PYXIS MEDFLEX MN 2000 2HH-3FM-1DD 139065-01 BD PYXIS MEDFLEX MN 2000 2HH-5FM 139058-01 BD PYXIS MEDFLEX MN 2000 3FM 139060-01 BD PYXIS MEDFLEX MN 2000 4HH-1FM 139067-01 BD PYXIS MEDFLEX MN 2000 4HH-4FM 139064-01 BD PYXIS MEDFLEX MN 2000 6FM 139059-01 BD PYXIS MEDFLEX MN 2000 6HH 139068-01 BD PYXIS MEDFLEX MN 2000 6HH-3FM 139165-01 BD PYXIS MEDFLEX MN 2000 8HH-2FH 139069-01 BD PYXIS MEDFLEX MN 2000 8HH-2FM 1139-00 MEDFLEX 2.0 1119-00 MEDFLEX. Reason: Labeling update to include a contraindication statement against the use of medicine cabinets in procedure and operating rooms..
- Recalling firm
- CareFusion 303, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-01-08
- Firm location
- San Diego, CA, United States
Product description
139054-01 BD PYXIS MEDFLEX MN 1000 10HH-1FM 139055-01 BD PYXIS MEDFLEX MN 1000 12HH 139053-01 BD PYXIS MEDFLEX MN 1000 2HH-2FH-3FM 139041-01 BD PYXIS MEDFLEX MN 1000 2HH-2FM 139046-01 BD PYXIS MEDFLEX MN 1000 2HH-5FM 139038-01 BD PYXIS MEDFLEX MN 1000 3FM 139040-01 BD PYXIS MEDFLEX MN 1000 4HH-1FM 139049-01 BD PYXIS MEDFLEX MN 1000 4HH-4FM 139044-01 BD PYXIS MEDFLEX MN 1000 6FM 139039-01 BD PYXIS MEDFLEX MN 1000 6HH 139051-01 BD PYXIS MEDFLEX MN 1000 6HH-3FM 139164-01 BD PYXIS MEDFLEX MN 1000 8HH-2FH 139052-01 BD PYXIS MEDFLEX MN 1000 8HH-2FM 139070-01 BD PYXIS MEDFLEX MN 2000 10HH-1FM 139071-01 BD PYXIS MEDFLEX MN 2000 12HH 139061-01 BD PYXIS MEDFLEX MN 2000 2HH-2FM 139066-01 BD PYXIS MEDFLEX MN 2000 2HH-3FM-1DD 139065-01 BD PYXIS MEDFLEX MN 2000 2HH-5FM 139058-01 BD PYXIS MEDFLEX MN 2000 3FM 139060-01 BD PYXIS MEDFLEX MN 2000 4HH-1FM 139067-01 BD PYXIS MEDFLEX MN 2000 4HH-4FM 139064-01 BD PYXIS MEDFLEX MN 2000 6FM 139059-01 BD PYXIS MEDFLEX MN 2000 6HH 139068-01 BD PYXIS MEDFLEX MN 2000 6HH-3FM 139165-01 BD PYXIS MEDFLEX MN 2000 8HH-2FH 139069-01 BD PYXIS MEDFLEX MN 2000 8HH-2FM 1139-00 MEDFLEX 2.0 1119-00 MEDFLEX
Reason for recall
Labeling update to include a contraindication statement against the use of medicine cabinets in procedure and operating rooms.
Data sourced from openFDA. This site is unofficial and independent of the FDA.