Recall Z-1901-2021 ยท KDM Sigmoidoscope, Rigid, Non-Electrical
Adler MicroMed, Inc.
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 Diag
| Date | Apr 23, 2021 |
| Status | Terminated |
| Reason | Due to issue with product sterility. Sterilization service provider had falsified records. |
| Root cause | Process control |
| 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 reca |
| Quantity | 1,858 devices |
| Distribution | US distribution: FL, IL, MA, and PA. |
| FDA record | Open on fda.gov |