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HomeBatrik Medical Manufacturing Inc › Vascular Silicones Ties, Mini Yellow, sterile

Vascular Silicones Ties, Mini Yellow, sterile

Batrik Medical Manufacturing Inc · Model 10-3202 · UDI-DI 00690521020719

HCF
5
510(k) clearances
635
Adverse events (6 deaths)
5
Recalls
164
Facilities

Description

Vascular Silicone Ties, Radio Opaque, Sterile, Mini Yellow, 0.075" x 32" / 0.2 cm x 81 cm

Recalls

DateFirmReason
2023-12-29Aesculap IncNeedle 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
2023-12-29Aesculap IncNeedle 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
2020-07-08New Wave Endo-Surgical, Corp.The plastic housing on the device may fracture
2016-11-16Teleflex MedicalThe devices wings may become partially detached from the EFx Shield during use.
2016-03-24Teleflex MedicalIncorrect expiration date was printed on the product label.

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Data 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.