TKMD
Anhui Tiankang Medical Technology Co., Ltd. · Model TKSN · UDI-DI 06934841570528
Description
The TK Safety Needle consists of a hypodermic needle with a hinged safety sheath attached to the needle hub. The safety sheath is simultaneously activated when manually pressed over the needle after use and prior to disposal to minimize the possibility of sharps injury. The safety sheath is activated with one-hand operation by pressing the sheath either with the finger or thumb, or by surface activation. The locking mechanism is positioned within the center and proximal end of the sheath. The hinge feature allows the medical practitioner the flexibility to adjust the sheath to its desired position for use.
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 |
| 2023-07-26 | embecta Medical II LLC | Retrospectively reported: Pen needles labeled 'For Investigational Use Only' were inadvertently distributed as commercially marketed devices. |
| 2023-07-26 | embecta Medical II LLC | Retrospectively reported: Pen needles labeled 'For Investigational Use Only' were inadvertently distributed as commercially marketed devices. |
| 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 |
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