Reported Feb 10, 2021 · Ongoing
FLOW COUPLER Monitor Flow Coupler devices are sold in 5 sizes (2.0 mm, 2.5 mm, 3.0 mm, 3.5 mm, 4.0 mm). Implantable…
Baxter Healthcare Corporation
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 Corporation · 1 Baxter Pkwy · Deerfield, IL · 60015-4625
Is this the product you have?
- FLOW COUPLER Monitor Flow Coupler devices are sold in 5 sizes (2.0 mm, 2.5 mm, 3.0 mm, 3.5 mm, 4.0 mm). Implantable device for vascular use.
- Lot codes and dates
- UDI00844735006148
- Product Code5156-00000-011
- Serial Numbers
109 of 109 codes
135306000279135306000280135306000281135306000282135306000283135306000284135306000286135306000287135306000288135306000289135306000290135306000291135306000292135306000293135306000294135306000295135306000298135306000299135306000300135306000301135306000303135306000304135306000305135591000306135591000307136959000309136959000310136959000311136959000312136959000313136959000314136959000315136959000316136959000317136959000318136959000319136959000320136959000321136959000322136959000323136959000324136959000325136959000326136959000327136959000328136959000329136959000330136959000331136959000332136959000333136959000334136959000335136959000336136959000337136959000338136959000339136959000340136959000341136959000342136959000344
- Amount recalled
- 109 units
Where it was sold
Why it was recalled
Potential for the battery to lose its ability to be recharged.
This product could cause temporary or reversible health problems — stop using it.
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