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Polyp Collection Kit
Micro-Tech (Nanjing) Co., Ltd. · Model BBP-50 · UDI-DI 06932503554015
KDQ
Prescription
10
510(k) clearances
2,074
Adverse events (55 deaths)
33
Recalls
274
Facilities
Description
The product is used to collect tissue samples of the diameter larger than 1mm and can be drawn through the endoscope through the suction device, which can be used for pathological analysis.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-06-27 | MEDLINE INDUSTRIES, LP - Northfield | Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the pote |
| 2024-03-22 | MEDLINE INDUSTRIES, LP - Northfield | A slight dimensional variation which has the potential for increased difficulty fitting into outer canister. |
| 2024-03-22 | MEDLINE INDUSTRIES, LP - Northfield | A slight dimensional variation which has the potential for increased difficulty fitting into outer canister. |
| 2024-03-22 | MEDLINE INDUSTRIES, LP - Northfield | A slight dimensional variation which has the potential for increased difficulty fitting into outer canister. |
| 2024-03-22 | MEDLINE INDUSTRIES, LP - Northfield | A slight dimensional variation which has the potential for increased difficulty fitting into outer canister. |
| 2024-03-22 | MEDLINE INDUSTRIES, LP - Northfield | A slight dimensional variation which has the potential for increased difficulty fitting into outer canister. |
| 2024-03-22 | MEDLINE INDUSTRIES, LP - Northfield | A slight dimensional variation which has the potential for increased difficulty fitting into outer canister. |
| 2024-03-22 | MEDLINE INDUSTRIES, LP - Northfield | A slight dimensional variation which has the potential for increased difficulty fitting into outer canister. |
| 2023-09-05 | Atrium Medical Corporation | Product was re-processed and re-sterilized by a third party using packaging configurations and a sterilization process which are not approved by the manufacture and lack validation |
| 2023-03-01 | Atrium Medical Corporation | The Instructions for Use (IFU) for the Pneumostat Chest Drain Valve and the Express Mini 500 Dry Seal Chest Drains do not provide sufficient precaution against draining the device |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.