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Recall Observatory FDA recall evidence

Device product

Brand Name: MEDLINE Product Name: SYR 5ML L/L PURPLE Model/Catalog Number: 91841 Product Description: NON-Sterile syringes without needles for single use Component: No

Z-2073-2024

April 05, 2024

Class II

Product summary

Firm
Jiangsu Shenli Medical Production Co., Ltd.
Event
Event 94520
Status
Ongoing
Classification
Class II
Quantity
0
Official record key
device-enforcement:Z-2073-2024

Official wording

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

Code information: Lot Code: LOT: N/A

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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