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Recall Observatory FDA recall evidence

Device product

Surgical convenience kits labeled as: a) CENTURION MEDICAL PRODUCTS CENTRAL LINE DRESSING CHANGE K, Reorder Number DT21400; b) CENTURION MEDICAL PRODUCTS CUSTOM PORT ACCESS KIT, Reorder Number DT22255; c) MEDLINE CVC DRESSING CHANGE KIT, Reorder Number DYNDC1022GB,

Z-1124-2023

December 07, 2022

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 91483
Status
Ongoing
Classification
Class II
Quantity
1588 units
Official record key
device-enforcement:Z-1124-2023

Official wording

Reason: The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.

Code information: a) Reorder Number DT21400, GTIN 40653160318225 Lot # 22HMH962; b) Reorder Number DT22255, GTIN 40653160328644 Lot # 22HMH427; c) Reorder Number DYNDC1022GB, GTIN 40195327038701 Lot # 22GBY236

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.