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Cambridge Sensors USA LLC · Model 531-10 · UDI-DI 00847713000763
1
510(k) clearances
39,692
Adverse events (67 deaths)
309
Recalls
448
Facilities
Description
Safety Pen Needles With Dual Automatic Protective Shields (31g 5mm)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-30 | Bard Access Systems, Inc. | After placement of intraosseous (IO) needle sets, used when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases, users may exp |
| 2025-06-05 | Waismed Ltd. | Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion. |
| 2025-06-05 | Waismed Ltd. | Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion. |
| 2024-11-19 | Greiner Bio-One GmbH | The VACUETTE SAFELINK Holder with male luer lock may leak blood due to the protective rubber sleeve bunching up and not retracting when using the device. |
| 2024-06-18 | Embecta Corp. | BD Nano 2nd Gen Pen Needle was shipped close to or after the labeled expiration date of February 29, 2024. Using a device past its expiry sterility and integrity of the device cann |
| 2024-02-05 | Retractable Technologies, Inc. | The needle cannula of a retractable needle may detach from the needle holder in the patient. |
| 2023-08-22 | Apellis Pharmaceuticals, Inc. | 19-gauge x 1" inch filter needles showed appearances of a small fraction of non-preferred characteristics. A causal relationship has not been established between the structural var |
| 2022-06-20 | Bard Access Systems, Inc. | BD Intraosseous Needle Kits may exhibit: 1) Increased force required to remove the stylet from intraosseous needle during placement may cause removal of the entire needle assembly |
| 2021-08-24 | Zhejiang Kindly Medical Devices Co., Ltd. | Potential for difficulty in safety mechanism activation. |
| 2021-08-24 | Zhejiang Kindly Medical Devices Co., Ltd. | Potential for difficulty in safety mechanism activation. |
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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.