Reported Jun 30, 2021 · Terminated
Probe Cover, 6" x 96", PE, w 3 elastic bands- Ultrasonic Transducer Cover Item ID: E6443N
Exact Medical Manufacturing, Inc.
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: Exact Medical Manufacturing, Inc. · 4917 William St Ste C · Lancaster, NY · 14086-3200
Is this the product you have?
- Probe Cover, 6" x 96", PE, w 3 elastic bands-
- Ultrasonic Transducer Cover Item IDE6443N
- Lot codes and dates
- Lot Numbers
1906E3101908E2081908E5611910E0321910E3501911E2621912E5402003E3082002E1352003E3242004E5132009E1292009E4082101E0692011E404
- Lot Numbers
- Amount recalled
- 51300 units
This recall covers 18 products
The agency filed one notice per product. You are reading one of them; the other 17 are below.
5 more are in the archive.
Where it was sold
Why it was recalled
No 510k for the product to be used in a natural or surgical opening to the body
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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