Recall Z-1470-2015— Churchill Medical Systems, Inc.
Class II · Terminated
Class II FDA medical device recall by Churchill Medical Systems, Inc., initiated 2015-01-15, terminated 2016-02-25. It names 3 FDA 510(k) clearances: K070705, K021395, K963981. Product: 4" Microbore Trifurcated Ext set, Product Code: BN-308 Accessory device used to administer medical fluids. Reason: Potential for leaking caused by insufficient bond between needleless device and female luer..
- Recalling firm
- Churchill Medical Systems, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-01-15
- Terminated
- 2016-02-25
- Firm location
- Dover, NH, United States
510(k) clearances named in this recall
3 on FDA's record- K070705 — MODIFICATION TO: LATEX-FREE BIONECTOR, MODEL# 896.019, 896.039
- K021395 — MODIFICATION TO 30 EXTENSION SET
- K963981 — VYGON BIONECTOR WITH EXTENSION 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
4" Microbore Trifurcated Ext set, Product Code: BN-308 Accessory device used to administer medical fluids
Reason for recall
Potential for leaking caused by insufficient bond between needleless device and female luer.
Data sourced from openFDA. This site is unofficial and independent of the FDA.