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FDA-Device2024-05-29Not Yet ClassifiedMISBRANDING

Medline 30mL syringes recalled for non-compliance with FDA clearance specifications

Shenli
FALSE CLAIMS
CAFLGAILTNVA

Check Medline syringe lot codes; contact supplier

Medline 30mL non-sterile syringes (model 83078) do not match the size and design specifications that the FDA cleared for this product. Over 4 million units across multiple lot codes were distributed to healthcare facilities in six states. No injuries have been reported.

  • Check your syringes against the affected lot codes listed in the recall notice
  • Contact your Medline supplier or the distributor if you have affected lots
  • Do not use syringes from the recalled lot codes
  • Report any issues or injuries to the FDA
Hazard

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

Sold states
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.
Affected count
4092250
Manufactured in
No. 20 Changzheng Road, Zhengluzhen Wujin, Changzhou, China
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=94520

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