Reported Jun 30, 2021 · Terminated
Sapi Med sterile disposable colorectal anoscopes and proctoscopes. REF/Product Description
Adler MicroMed, 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: Adler MicroMed, Inc. · 6842 Elaine Way · San Diego, CA · 92120-3933
Is this the product you have?
Sapi Med sterile disposable colorectal anoscopes and proctoscopes. REF/Product Description
5 of 5 products
| # | Product as published |
|---|---|
| 1 | 4083/THE BEAK - Surgical proctoscope. Disposable & sterile. Transparent. Self light |
| 2 | 4519/MPR Short - Multi Purpose Rectoscope. 190mm long. Sterile & Disposable |
| 3 | 4086/EPOFLIER - Surgical kit made of a 34,3mm wide anoscope and an opened retractor named GULL. Disposable & sterile |
| 4 | 4084/THE BEAK Diagnostic- Disposable proctoscope. Transparent. Sterile & Self lighting |
| 5 | 4522/ MPR - Multi Purpose Rectoscope. 220mm long. Sterile & Disposable |
- Lot codes and dates
6 of 6 products
Products covered by this recall Model / number Product as published — REF Numbers/Lot Numbers A.4083/Lot Numbers: 18D004l, 19C010l, 19l018l, 20l027l A.4084/LotNumber: 19l015l A.4519/LotNumbers: 18l013l, 18l012l, 19D002l, 19F012l A.4522/LotNumbers: 18G003l, 19K023l A.4086/LotNumber: 18F027l; Sterilization Batch Numbers: 18042311; 18092611; 18071211_1; 19040512; 18073112; 19092713; 19120612; 19063012; 20102212; 19063012 - Amount recalled
- 1,858 devices
Where it was sold
Why it was recalled
Due to issue with product sterility. Sterilization service provider had falsified records.
This product could cause temporary or reversible health problems — stop using it.
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