Adler MicroMed, Inc. Recall 87812
Description: Sapi Med sterile disposable colorectal anoscopes and proctoscopes. REF/Product Description: A.4083/THE BEAK - Surgical proctoscope. Disposable & sterile. Transparent. Self light; A.4519/MPR Short - Multi Purpose Rectoscope. 190mm long. Sterile & Disposable; A.4086/EPOFLIER - Surgical kit made of a 34,3mm wide anoscope and an opened retractor named GULL. Disposable & sterile; A.4084/THE BEAK Diagnostic- Disposable proctoscope. Transparent. Sterile & Self lighting; A.4522/ MPR - Multi Purpose Rectoscope. 220mm long. Sterile & Disposable
Adler MicroMed, Inc. Recall 87812 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1901-2021 |
| Event ID | 87812 |
| Event Description | Sapi Med sterile disposable colorectal anoscopes and proctoscopes. REF/Product Description: A.4083/THE BEAK - Surgical proctoscope. Disposable & sterile. Transparent. Self light; A.4519/MPR Short - Multi Purpose Rectoscope. 190mm long. Sterile & Disposable; A.4086/EPOFLIER - Surgical kit made of a 34,3mm wide anoscope and an opened retractor named GULL. Disposable & sterile; A.4084/THE BEAK Diagnostic- Disposable proctoscope. Transparent. Sterile & Self lighting; A.4522/ MPR - Multi Purpose Rectoscope. 220mm long. Sterile & Disposable |
| Product Type | Devices |
| Distribution | US distribution: FL, IL, MA, and PA. |
| Quantity | 1,858 devices |
| Recall Reason | Due to issue with product sterility. Sterilization service provider had falsified records. |
| Device Classification | 20210630 |
| Device Code Info | REF Numbers/Lot Numbers: REF A.4083 /Lot Numbers: 18D004l, 19C010l, 19l018l, 20l027l; REF A.4084/Lot Number: 19l015l; REF A.4519/Lot Numbers: 18l013l, 18l012l, 19D002l, 19F012l; REF A.4522/Lot Numbers: 18G003l, 19K023l; REF A.4086/Lot Number: 18F027l; Sterilization Batch Numbers: 18042311; 18092611; 18071211_1; 19040512; 18073112; 19092713; 19120612; 19063012; 20102212; 19063012; |
| Center Classification Date | 20210621 |
| Recall Initiation Date | 20210423 |
| Recalling Firm | Adler MicroMed, Inc. |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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