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Recall Observatory FDA recall evidence

Device product

Brand Name: MEDLINE Product Name: SYR 30ML L/L Model/Catalog Number: 83078 Product Description: NON-Sterile syringes without needles for single use Component: No

Recall number unavailable

April 05, 2024

Not Yet Classified

Product summary

Firm
Jiangsu Shenli Medical Production Co., Ltd.
Event
Event 94520
Status
Ongoing
Classification
Not Yet Classified
Quantity
4092250
Official record key
device-enforcement:pending:94520:f5c4b9b632d5fce7549b2baa9ae33e5e4e933e3422518c229cb939137517c0b6

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: 63720120007,63721010002,63721050002,63721060002,63721070001,63721070004,63721070006, 63721080001,63721080002,63721080003,63721080004,63721080005,63721090001,63721090004, 63721090005,63721100001,63721100002,63721110002,63721110003,63721120001,63721120004, 63722010001,63722020002,63722030001,63722030003,63722030004,63722040004,63722040006, 63722050001,63722050006,63722060001,63722060002,63722060003,63722060006,63722070002, 63722070004,63722080002,63722080004,63722080005,63722080006,63722090002,63722120002, 63722120003,63723010002,63723020001,63723050001,63723050002,63723060001,63723070001, 63723070003,63723080001,63723080002,63723080003,63723090002,63723100003,63723110001, 63723120002

Distribution pattern: U.S.: 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).