Autokeeper
MEDEXEL CO.,LTD. · Model Safety Pen Needle 34G x 4mm 100PCS · UDI-DI 08809445831505
Description
Autokeeper® Safety Pen Needles are single use, sterile, medical devices designed to be used in conjunction with insulin pen injectors. Pen needles are used by consumers, caregivers and health care professionals. They are offered in six gauge sizes (29G, 30G, 31G, 32G, 33G and 34G) and lengths (4mm, 5mm, 6mm and 8mm). This device is sterile (EO gas sterilization). Additionally, the attached safety shield automatically locks in place and is intended to help reduce the occurrence of accidental needle sticks from the patient end of the needle. The shield also serves to hide the needle before and after injection. This device is assembly consists of Sterile cap, Needle cap, Middle cap, Spring, Needle, Safety shield, hub and sterile paper.
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 |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docs