Recall Z-0350-2024— Becton Dickinson & Company
Class II · Ongoing
Class II FDA medical device recall by Becton Dickinson & Company, initiated 2023-10-11. It names 2 FDA 510(k) clearances: K022209, K882302. Product: BD gravity sets (Product Name, Catalog #) 32-IN GRAV SET W/0.2 MICRON FILTER BAG ACCESS PORT SS VALVE TEXIUMTM LOW ABSORPTION, Catalog # 4030B-07T and BD GRAVITY BLOOD SET 15 DROP 180 MICRON FILTER SmartSiteTM VALVE NONVENTED, Catalog # 42081E.. Reason: Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP)..
- Recalling firm
- Becton Dickinson & Company
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-10-11
- Firm location
- Franklin Lakes, NJ, United States
510(k) clearances named in this recall
2 on FDA's record- K022209 — ALARIS MEDICAL INFUSION SYSTEM ADMINISTRATION SETS
- K882302 — IVAC(R) UNVENTED VOL. INFUSION SET MODEL 52080
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
BD gravity sets (Product Name, Catalog #) 32-IN GRAV SET W/0.2 MICRON FILTER BAG ACCESS PORT SS VALVE TEXIUMTM LOW ABSORPTION, Catalog # 4030B-07T and BD GRAVITY BLOOD SET 15 DROP 180 MICRON FILTER SmartSiteTM VALVE NONVENTED, Catalog # 42081E.
Reason for recall
Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP).
Data sourced from openFDA. This site is unofficial and independent of the FDA.