FDA Device recall Z-1536-2015

The Patient Control Module (PCM) is used in conjunction with a Baxter infusor as a single use device for the control of intermittent bolus…

FDA Device
Class II
terminated
Published 2015-05-06

On 2015-05-06 the FDA classified a Class II recall of The Patient Control Module (PCM) is used in conjunction with a Baxter infusor as a single use device for the control of intermittent bolus… by Baxter Healthcare, citing potential for device malfunction resulting in flow when the device should not be flowing.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1536-2015
Classification	Class II
Status	terminated
Initiated	2014-04-17
Published	2015-05-06
Last updated	2026-09-13 11:53 UTC
Company	Baxter Healthcare
Distribution	FL

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

Identifiers

code_info	1) Product Code: 2C1067; Lots and Expiration Dates: Lot 11D001 , Expires 4/1/2014 ; Lot 11D068 , Expires 4/1/2014 ; L… 1) Product Code: 2C1067; Lots and Expiration Dates: Lot 11D001 , Expires 4/1/2014 ; Lot 11D068 , Expires 4/1/2014 ; Lot 11E048 , Expires 5/1/2014 ; Lot 11E084 , Expires 5/1/2014 ; Lot 11F050 , Expires 6/1/2014 ; Lot 11G019 , Expires 7/1/2014 ; Lot 11H019 , Expires 8/1/2014 ; Lot 11H074 , Expires 8/1/2014 ; Lot 11J042 , Expires 9/1/2014 ; Lot 11J078 , Expires 9/1/2014 ; Lot 11M078 , Expires 11/1/2014 ; Lot 11N027 , Expires 12/1/2014 ; Lot 12A020 , Expires 1/1/2015 ; Lot 12A037 , Expires 1/1/2015 ; Lot 12A050 , Expires 1/1/2015 ; Lot 12A095 , Expires 2/1/2015 ; Lot 12B040 , Expires 2/1/2015 ; Lot 12C033 , Expires 3/1/2015 ; Lot 12D016 , Expires 4/1/2015 ; Lot 12D041 , Expires 4/1/2015 ; Lot 12D089 , Expires 4/1/2015 ; Lot 12E004 , Expires 5/1/2015 ; Lot 12F010 , Expires 6/1/2015 ; Lot 12F036 , Expires 6/1/2015 ; Lot 12G032 , Expires 7/1/2015 ; Lot 12G034 , Expires 7/1/2015 ; Lot 12G057 , Expires 7/1/2015 ; Lot 12H012 , Expires 7/1/2015 ; Lot 12H033 , Expires 8

code_info

1) Product Code: 2C1067; Lots and Expiration Dates: Lot 11D001 , Expires 4/1/2014 ; Lot 11D068 , Expires 4/1/2014 ; L…

1) Product Code: 2C1067; Lots and Expiration Dates: Lot 11D001 , Expires 4/1/2014 ; Lot 11D068 , Expires 4/1/2014 ; Lot 11E048 , Expires 5/1/2014 ; Lot 11E084 , Expires 5/1/2014 ; Lot 11F050 , Expires 6/1/2014 ; Lot 11G019 , Expires 7/1/2014 ; Lot 11H019 , Expires 8/1/2014 ; Lot 11H074 , Expires 8/1/2014 ; Lot 11J042 , Expires 9/1/2014 ; Lot 11J078 , Expires 9/1/2014 ; Lot 11M078 , Expires 11/1/2014 ; Lot 11N027 , Expires 12/1/2014 ; Lot 12A020 , Expires 1/1/2015 ; Lot 12A037 , Expires 1/1/2015 ; Lot 12A050 , Expires 1/1/2015 ; Lot 12A095 , Expires 2/1/2015 ; Lot 12B040 , Expires 2/1/2015 ; Lot 12C033 , Expires 3/1/2015 ; Lot 12D016 , Expires 4/1/2015 ; Lot 12D041 , Expires 4/1/2015 ; Lot 12D089 , Expires 4/1/2015 ; Lot 12E004 , Expires 5/1/2015 ; Lot 12F010 , Expires 6/1/2015 ; Lot 12F036 , Expires 6/1/2015 ; Lot 12G032 , Expires 7/1/2015 ; Lot 12G034 , Expires 7/1/2015 ; Lot 12G057 , Expires 7/1/2015 ; Lot 12H012 , Expires 7/1/2015 ; Lot 12H033 , Expires 8

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1536-2015%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.