Recall Z-0937-2020— B. Braun Medical, Inc.
Class II · Terminated
Class II FDA medical device recall by B. Braun Medical, Inc., initiated 2019-11-20, terminated 2020-10-16. It names 5 FDA 510(k) clearances: K140311, K083723, K060231 and 2 more. Product: Y-Type Blood Set, Catalog Number 490314. Reason: Potential for leakage at the joint between the blood filters and tubing.
- Recalling firm
- B. Braun Medical, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-11-20
- Terminated
- 2020-10-16
- Firm location
- Allentown, PA, United States
510(k) clearances named in this recall
5 on FDA's record- K140311 — CARESITE LUER ACCESS DEVICE
- K083723 — A6 LUER ACCESS DEVICE
- K060231 — CLOSED SWABABLE STOPCOCK AND MINIMAL RESIDUAL VOLUME LUER-ACTIVATED SWABABLE-STOPCOCK
- K922637 — HORIZON PUMP Y-TYPE BLOOD SET
- K840212 — CONCENTRATED PLATELET ADMIN. SET
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
Y-Type Blood Set, Catalog Number 490314
Reason for recall
Potential for leakage at the joint between the blood filters and tubing
Data sourced from openFDA. This site is unofficial and independent of the FDA.