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Recall Observatory FDA recall evidence

Device product

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. KIT TRIAGE ADMIT, Model Number: DYKA1456; b. KIT,ANTE PARTUM, Model Number: DYKL1844; c. MATERNAL ADMIT KIT, Model Number: DYKM2091

Z-2330-2023

May 15, 2023

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 92399
Status
Ongoing
Classification
Class II
Quantity
7,040 kits
Official record key
device-enforcement:Z-2330-2023

Official wording

Reason: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

Code information: All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: DYKA1456, UPC Number: 019532723188. b. Model Number: DYKL1844, UPC Number: 019532723181. c. Model Number: DYKM2091, UPC Number: 019348998356.

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.