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Recall Observatory FDA recall evidence

Device product

Centurion procedure kits labeled as: 1) BONE MARROW TRAY, Pack Number SPEC0255; 2) CT/ULTRASOUND BIOPSY, Pack Number SPEC0262; 3) FINE LACERATION KIT, Pack Number SUT17215; 4) INFECTION DRIVELINE MANAGEMENT KIT, Pack Number DM645; 5) LACERATION TRAY, Pack Number DYNDL1159B; 6) SUTURE TRAY, Pack Number DYNDS1064B

Z-2770-2024

April 08, 2024

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 94585
Status
Ongoing
Classification
Class II
Quantity
Unavailable
Official record key
device-enforcement:Z-2770-2024

Official wording

Reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information: SPEC0255, Lot Number 2020042080: SPEC0262, Lot Number 2018111280: SUT17215, Lot Number 2020042080: DM645, Lot Number 2018111280: DM645, Lot Number 2020042080: DM645, Lot Number 2022020780: DYNDL1159B, Lot Number 2018111280: DYNDS1064B, Lot Number 2020042080

Distribution pattern: worldwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.