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
FDA Recall Z-1901-2021 · Posted None
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Recalling FirmAdler MicroMed, Inc.
Recall StatusTerminated
Product CodeKDM
Date Initiated2021-04-23
Date Terminated2022-10-04
Product Quantity1,858 devices
Reason for Recall
Due to issue with product sterility. Sterilization service provider had falsified records.
Firm Action
On 04/23/2021, the Recalling Firm communicated an URGENT: MEDICAL RECALL message via a telephone calls to customers and followed up email with a notification letter, informing them that the affected products that are labeled as sterile may not be sterile and the products could affect the sterile field and cause patient infections.
Customers are instructed to:
1) Segregate and quarantine the affected products and wait for further instructions for disposition to follow, and
2) Complete and return the attached Acknowledgement and Receipt Form and indicate the quantities and location of the recalled products.
Root Cause
Process control
Distribution Pattern
US distribution: FL, IL, MA, and PA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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