PlainRecalls
FDA Devices Moderate Class II Terminated

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 Pu

Reported: June 30, 2021 Initiated: April 23, 2021 #Z-1901-2021

Product 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

Reason for Recall

Due to issue with product sterility. Sterilization service provider had falsified records.

Details

Recalling Firm
Adler MicroMed, Inc.
Units Affected
1,858 devices
Distribution
US distribution: FL, IL, MA, and PA.
Location
San Diego, CA

Frequently Asked Questions

What product was recalled? ▼
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. Recalled by Adler MicroMed, Inc.. Units affected: 1,858 devices.
Why was this product recalled? ▼
Due to issue with product sterility. Sterilization service provider had falsified records.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 30, 2021. Severity: Moderate. Recall number: Z-1901-2021.

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