Baxter Patient Control Modules Recalled for Potential Malfunction
Baxter Healthcare is recalling 7,596 Patient Control Modules due to a potential malfunction that could cause medication to flow when it should not.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a medical device malfunction that could lead to unintended medication flow, which is a significant injury risk.
Plain-English summary
Baxter Healthcare Corp. is recalling 7,596 Patient Control Modules (PCM) under FDA recall number Z-1536-2015. The PCM is a single-use device used with a Baxter infusor to control intermittent bolus doses of medication based on patient demand. The recall covers specific lots of product codes 2C1067 and 2C1067K, with expiration dates ranging from April 2014 to February 2017.
The recall was initiated because of a potential for device malfunction that could result in medication flow when the device should not be flowing. This defect poses a risk of unintended medication administration to patients using the device.
The affected units were distributed worldwide, including in the United States (specifically Florida) and in Belgium, Denmark, Germany, Italy, Japan, Norway, Poland, South Korea, Spain, Sweden, and the United Arab Emirates. Healthcare facilities and patients should stop using the affected lots and contact Baxter Healthcare or the FDA for further instructions.
The recalled product
- 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.
- Manufacturer
- Baxter Healthcare Corp.
- Affected units
- 7,596
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 1) Product Code: 2C1067
- Lots and Expiration Dates: Lot 11D001
- Expires 4/1/2014
- Lot 11D068
- Lot 11E048
- Expires 5/1/2014
- Lot 11E084
- Lot 11F050
- Expires 6/1/2014
- Lot 11G019
- Expires 7/1/2014
- Lot 11H019
- Expires 8/1/2014
- Lot 11H074
- Lot 11J042
- Expires 9/1/2014
- Lot 11J078
- Lot 11M078
- Expires 11/1/2014
- Lot 11N027
Distribution
Distributed in 1 state:
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