The Patient Control Module (PCM) is used in conjunction with a Baxter infusor as a single use dev...
FDA Device Recall #Z-1536-2015 — Class II — April 17, 2014
Recall Summary
| Recall Number | Z-1536-2015 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 17, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Baxter Healthcare Corp. |
| Location | Deerfield, IL |
| Product Type | Devices |
| Quantity | 7,596 patient control modules |
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
Distribution Pattern
Worldwide Distribution - US Distribution to the state of FL., and to the countries of : Belgium, Denmark, Germany, Italy, Japan, Norway, Poland, South Korea, Spain, Sweden and United Arab Emirates.
Lot / Code Information
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 8/1/2015 ; Lot 12H077 , Expires 8/1/2015 ; Lot 12J047 , Expires 9/1/2015 ; Lot 12K008 , Expires 10/1/2015 ; Lot 12M036 , Expires 11/1/2015 ; Lot 12N031 , Expires 12/1/2015 ; Lot 13A016 , Expires 1/1/2016 ; Lot 13A084 , Expires 1/1/2016 ; Lot 13B037 , Expires 2/1/2016 ; Lot 13C018 , Expires 3/1/2016 ; Lot 13D012 , Expires 4/1/2016 ; Lot 13E009' , Expires 5/1/2016 ; Lot 13E034' , Expires 5/1/2016 ; Lot 13F044 , Expires 6/1/2016 ; Lot 13F058 , Expires 6/1/2016 ; Lot 13G026 , Expires 7/1/2016 ; Lot 13H025 , Expires 8/1/2016 ; Lot 13H081 , Expires 8/1/2016 ; Lot 13J007 , Expires 9/1/2016 ; Lot 13M052 , Expires 11/1/2016 ; Lot 13N008 , Expires 12/1/2016 ; Lot 14A019 , Expires 1/1/2017 ; Lot 14A033 , Expires 1/1/2017 ; Lot 14B015 , Expires 2/1/2017 ; 2) Product Code: 2C1067K; Lots and Expiration Dates: Lot 11E025 , Expires 5/31/2014 ; Lot 11H035 , Expires 8/31/2014 ; Lot 11N025 , Expires 12/31/2014 ; Lot 12D061 , Expires 4/30/2015 ; Lot 12F012 , Expires 6/1/2015 ; Lot 12K024 , Expires 10/31/2015 ; Lot 13A047 , Expires 1/31/2016 ; Lot 13H067 , Expires 8/31/2016 ; Lot 13N025 , Expires 12/31/2016 ; Lot 13N026 , Expires 12/31/2016 ; Lot 13N027 , Expires 12/31/2016 ; Lot 13N045 , Expires 12/31/2016
Other Recalls from Baxter Healthcare Corp.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0370-2017 | Class II | GAMBRO Capillary Dialyzer, Polyflux(R) Revaclea... | Oct 12, 2016 |
| Z-0670-2017 | Class II | sigma spectrum VOLUMETRIC INFUSION PUMP with Ma... | Sep 28, 2016 |
| Z-0671-2017 | Class II | Baxter SIGMA Spectrum INFUSION PUMP with Master... | Sep 28, 2016 |
| Z-0672-2017 | Class II | V6 Rear Case Assembly, Product Code 35701, a re... | Sep 28, 2016 |
| Z-2533-2016 | Class II | Synovis VASCU-GUARD Peripheral Vascular Patch i... | Jun 24, 2016 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.