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HSW NORM-JECT
Henke-Sass, Wolf GmbH · Model 8300014600 · UDI-DI 04035873036210
KYW
Prescription
2
510(k) clearances
209
Adverse events
13
Recalls
215
Facilities
Description
20ML (24ML) HSW NORM-JECT ORAL
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-10-14 | Becton Dickinson & Company | BD has confirmed through internal testing that certain device trays failed routine biocompatibility testing. |
| 2024-05-09 | Sol-Millennium Medical Inc. | Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use. |
| 2022-07-04 | Medicina Uk Ltd | Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification |
| 2022-07-04 | Medicina Uk Ltd | Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification |
| 2022-07-04 | Medicina Uk Ltd | Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification |
| 2022-07-04 | Medicina Uk Ltd | Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification |
| 2022-07-04 | Medicina Uk Ltd | Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification |
| 2022-07-04 | Medicina Uk Ltd | Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification |
| 2022-07-04 | Medicina Uk Ltd | Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification |
| 2022-07-04 | Medicina Uk Ltd | Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification |
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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.