Recall Z-1484-2017— Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.

Name: FDA recall Z-1484-2017
Creator: U.S. Food and Drug Administration
Published: 2017-02-20

Class II · Terminated

Class II FDA medical device recall by Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc., initiated 2017-02-20, terminated 2019-04-22. It names one FDA 510(k) clearance: K021395. Product: AMS-636, 60" Microbore extension set. Product Usage: Accessory devices used to administer medical fluids.. Reason: Incorrect priming volume printed on the device package..

Recalling firm: Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-02-20
Terminated: 2019-04-22
Firm location: Dover, NH, United States

510(k) clearances named in this recall

1 on FDA's record

K021395 — MODIFICATION TO 30 EXTENSION SETChurchill Medical Systems, Inc.·cleared 2002-05-13

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

AMS-636, 60" Microbore extension set. Product Usage: Accessory devices used to administer medical fluids.

Reason for recall

Incorrect priming volume printed on the device package.

Data sourced from openFDA. This site is unofficial and independent of the FDA.