| Date Initiated by Firm | April 23, 2021 |
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| Create Date | June 21, 2021 |
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| Recall Status1 |
Terminated 3 on October 04, 2022 |
| Recall Number | Z-1901-2021 |
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| Recall Event ID |
87812 |
| 510(K)Number | K070913 K070915 |
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| Product Classification |
Sigmoidoscope, rigid, non-electrical - Product Code KDM
|
| 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 |
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| Code Information |
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; |
Recalling Firm/
Manufacturer |
Adler MicroMed, Inc.
6842 Elaine Way
San Diego CA 92120-3933
|
| For Additional Information Contact | Brian Chandler
484-995-7919 |
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Manufacturer Reason
for Recall | Due to issue with product sterility. Sterilization service provider had falsified records. |
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FDA Determined
Cause 2 | Process control |
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| 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. |
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| Quantity in Commerce | 1,858 devices |
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| Distribution | US distribution: FL, IL, MA, and PA. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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| 510(K) Database | 510(K)s with Product Code = KDM
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