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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. C V MINOR PACK, Model Number: DYNJ64862A; b. DBD-C SECTION ADM, Model Number: DYKL1816; c. FETAL SURGERY, Model Number: DYNJ908118A;

Z-2334-2023

May 15, 2023

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 92399
Status
Ongoing
Classification
Class II
Quantity
371 kits
Official record key
device-enforcement:Z-2334-2023

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: DYNJ64862A, UPC Number: 019348942033. b. Model Number: DYKL1816, UPC Number: 019532705432. c. Model Number: DYNJ908118A, UPC Number: 019532730349.

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.