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Laceration Tray

FDA product code PKD · Class 1 · General, Plastic Surgery

309
Registered devices
0
Adverse events
11
Recalls
0
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2026-03-19Medline Industries, LPDuring an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market
2026-01-07Medline Industries, LPMedline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster
2026-01-07Medline Industries, LPMedline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster
2025-12-24Medline Industries, LPMedline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibi
2024-11-21MEDLINE INDUSTRIES, LP - NorthfieldCustom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin conta
2024-10-09MEDLINE INDUSTRIES, LP - NorthfieldMedline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
2024-09-04MEDLINE INDUSTRIES, LP - NorthfieldIt has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product
2024-04-08MEDLINE INDUSTRIES, LP - NorthfieldMedical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee
2023-11-15MEDLINE INDUSTRIES, LP - NorthfieldMedline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irr
2023-05-15MEDLINE INDUSTRIES, LP - NorthfieldPotential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.