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ELMED
ELMED INCORPORATED · Model EL-SU16061 · UDI-DI 00842180176331
HCF
Prescription
5
510(k) clearances
635
Adverse events (6 deaths)
5
Recalls
164
Facilities
Description
Vital™ Mayo-Hegar needle holders, Tungsten carbide inserts. 2,500 teeth per square inch. Overall length 7-1/4in (18.4cm)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-12-29 | Aesculap Inc | Needle Holder MB215R was inadvertently distributed as MB362R. Similarly, MB362R was distributed as MB215R during the affected distribution date range. The issue may lead to a short |
| 2023-12-29 | Aesculap Inc | Needle Holder MB215R was inadvertently distributed as MB362R. Similarly, MB362R was distributed as MB215R during the affected distribution date range. The issue may lead to a short |
| 2020-07-08 | New Wave Endo-Surgical, Corp. | The plastic housing on the device may fracture |
| 2016-11-16 | Teleflex Medical | The devices wings may become partially detached from the EFx Shield during use. |
| 2016-03-24 | Teleflex Medical | Incorrect expiration date was printed on the product label. |
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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.