Reported May 6, 2015 · Terminated
The Patient Control Module (PCM) is used in conjunction with a Baxter infusor as a single use device for the control of…
Baxter Healthcare Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Baxter Healthcare Corp. · 1 Baxter Pkwy · Deerfield, IL · 60015-4625
Is this the product you have?
- 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.
- Lot codes and dates
66 of 66 products
Products covered by this recall Model / number Product as published 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 - Amount recalled
- 7,596 patient control modules
Where it was sold
Why it was recalled
Potential for device malfunction resulting in flow when the device should not be flowing
This product could cause temporary or reversible health problems — stop using it.
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