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Recall Observatory FDA recall evidence

Device product

Surgical convenience kits labeled as: a) MEDLINE GENERAL UTILITY, Reorder Number DYNDA2524 b) CENTURION MEDICAL PRODUCTS DIALYSIS ON/OFF BUNDLE, Reorder Number DT22705A c) CENTURION MEDICAL PRODUCTS ULTRASOUND PIV BUNDLE, Reorder Number IV8635D d) CENTURION MEDICAL PRODUCTS CUTDOWN TRAY, Reorder Number MNS12595

Z-1118-2023

December 07, 2022

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 91483
Status
Ongoing
Classification
Class II
Quantity
630 units
Official record key
device-enforcement:Z-1118-2023

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 DYNDA2524, GTIN 40193489361415, Lot # 22HME893 b) Reorder Number DT22705A, GTIN 40653160993224, Lot # 22HMC897 c) Reorder Number IV8635D, GTIN 40653160990261, Lot# 22HMH318 d) Reorder Number MNS12595, GTIN 40653160991015, Lot # 22HMD598

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.