Recall Z-1901-2021— Adler MicroMed, Inc.

Name: FDA recall Z-1901-2021
Creator: U.S. Food and Drug Administration
Published: 2021-04-23

Class II · Terminated

Class II FDA medical device recall by Adler MicroMed, Inc., initiated 2021-04-23, terminated 2022-10-04. It names 2 FDA 510(k) clearances: K070913, K070915. Product: 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: Due to issue with product sterility. Sterilization service provider had falsified records..

Recalling firm: Adler MicroMed, Inc.
Classification: Class II
Status: Terminated
Initiated: 2021-04-23
Terminated: 2022-10-04
Firm location: San Diego, CA, United States

510(k) clearances named in this recall

2 on FDA's record

K070913 — SELF-LIGHT DISPOSABLE ANOSCOPESapimed S.P.A.·cleared 2007-08-10
K070915 — SAPIMED DISPOSABLE SIGMOIDOSCOPESapimed S.P.A.·cleared 2007-07-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.