Reported Aug 22, 2018 · Terminated
TomoSPOT REF 782, 782S, 783, 783S, 784, 784S, 785 & 785S Adhere to skin for marking and identifying moles in…
Beekley 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: Beekley Corporation · 1 Prestige Ln · Bristol, CT · 06010-7468
Is this the product you have?
- TomoSPOT REF 782, 782S, 783, 783S, 784, 784S, 785 & 785S Adhere to skin for marking and identifying moles in mammography.
- Lot codes and dates
16 of 16 products
Products covered by this recall Model / number Product as published 782— — Lot Numbers: 05311801 05211801 02221801 04181802 03051801 03071802 04181804 05081801 03131801 02121801 03301802 05141801 03141801 05101801 03271801 05161801 02161801 03021802 04111801 05011801 05171802 02211801 04051802 04271801 04251801 05161802 03141802 05181801 04121801 05221802 04161802 04171801 04181803 05301802 04241802 05011802 02271802 02271803 02071802 02261802 02261803 05291803 782S— — Lot Numbers: 02221801 03271801 04121801 783— — Lot Numbers: 04131801 03071801 02281801 03121801 05151801 04101801 05041801 03021801 05181803 02081801 03261801 05221801 02061801 04181801 04201801 05071801 03161801 04061801 05181802 04231802 03091802 03171801 783S— — Lot Numbers: 02221801 04021801 784— — Lot Numbers: 05231801 03061801 02261801 03211801 02141801 03211802 05091801 04261802 784S— — Lot Numbers: 02221801 04021801 04121801 785— — Lot Numbers: 05111801 04191801 785S— — Lot Numbers: 04021801 04121801 - Amount recalled
- 3,384,024 pieces in total.
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
There is a potential for imaging artifact to mimic calcifications on patient's mammograms
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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