FDAClass IIMay 29, 2024

Brand Name: MEDIGRATIVE Product Name: 100cc/ml recall

Brand Name: MEDIGRATIVE Product Name: 100cc/ml disposable luer lock syringe Model/Catalog Number: 10025 Product Description: Sterile syringes without…

Why was Brand Name: MEDIGRATIVE Product Name: 100cc/ml recalled?

Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI-DI code: 00853620005241 Lot Code: LOT: EJ117-5, EJ117-6, EJ117-7, EJ117-8, EJ117-9, EJ117-10, EJ117-11

Product
Brand Name: MEDIGRATIVE Product Name: 100cc/ml disposable luer lock syringe Model/Catalog Number: 10025 Product Description: Sterile syringes without…
Recalling firm
Jiangsu Shenli Medical Production Co., Ltd.
Quantity
110000
Distribution
U.S. Nationwide distribution in the states of CA, FL, GA, IL, TN, and VA. After customers place US orders, then arrange production, then deliver to the cargos to customer designated port or warehouse, mostly in Shanghai port. The shipping company will ship the cargos to different destination such as Chicago, Los Angeles, Long beach, Miami, Savannah, Nashville, and Norfolk.
Recall date
May 29, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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