FDA Device Intelligence
Home › Surgical Specialties México, S. de R.L. de C.V. › COLL-PLUG VAR-PK .2.3,.4 x 2MM

COLL-PLUG VAR-PK .2.3,.4 x 2MM

Surgical Specialties México, S. de R.L. de C.V. · Model C-PLUG-V · UDI-DI 00848782023769

LZU Prescription
10
510(k) clearances
163
Adverse events
4
Recalls
37
Facilities

Description

COLL-PLUG VAR-PK .2.3,.4 x 2MM

Recalls

DateFirmReason
2022-01-17Lacrimedics IncThe sterile pouch seal may contain channels that could affect the seal integrity and potentially compromise sterility.
2022-01-17Lacrimedics IncThe sterile pouch seal may contain channels that could affect the seal integrity and potentially compromise sterility.
2014-11-26Lacrimedics IncMoisture level may cause the VisiPlugST (or CollaSyn Plugs) to break apart, or crumble upon contact. The firm's data also suggests that a 4 year shelf life may not be sustained.
2006-07-06Oasis Medical IncLabeled with an incorrect diameter

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
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.