Recall Z-1536-2015— Baxter Healthcare Corp.

Name: FDA recall Z-1536-2015
Creator: U.S. Food and Drug Administration
Published: 2014-04-17

Class II · Terminated

Class II FDA medical device recall by Baxter Healthcare Corp., initiated 2014-04-17, terminated 2017-07-21. It names one FDA 510(k) clearance: K051253. Product: The Patient Control Module (PCM) is used in conjunction with a Baxter infusor as a single use device for the control of intermittent bolus doses of medication based on patient demand.. Reason: Potential for device malfunction resulting in flow when the device should not be flowing.

Recalling firm: Baxter Healthcare Corp.
Classification: Class II
Status: Terminated
Initiated: 2014-04-17
Terminated: 2017-07-21
Firm location: Deerfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K051253 — MODIFICATION TO: MULTIRATE INFUSOR SV )WITH AND WITHOUT PCM), MULTIRATE INFUSOR LV (WITH AND WITHOUT PCM)Baxter Healthcare Corp·cleared 2005-07-15

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

The Patient Control Module (PCM) is used in conjunction with a Baxter infusor as a single use device for the control of intermittent bolus doses of medication based on patient demand.

Reason for recall

Potential for device malfunction resulting in flow when the device should not be flowing

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