Z-2099-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- May 29, 2024
- Initiation Date
- April 5, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9050240
Product Description
Brand Name: MEDLINE Product Name: SYR 10ML L/L CONTROL Model/Catalog Number: 91881 Product Description: NON-Sterile syringes without needles for single use Component: No
Reason for Recall
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
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.
Code Information
Lot Code: LOT: 63721010001,63721010003,63721040002,63721050 002,63721060001,63721070001,63721070002, 63721070003,63721070004,63721070006,63721080 001,63721080002,63721080003,63721080004, 63721080005,63721090001,63721090003,63721090 004,63721090005,63721100001,63721110001, 63721110002,63721110003,63721120002,63721120 003,63721120004,63722010001,63722020002, 63722030001,63722030002,63722030003,63722030 004,63722040002,63722040004,63722050001, 63722050002,63722050003,63722060002,63722060003,63722060006,63722070002,63722070004, 63722070005,63722070006,63722080003,63722080 005,63722080006,63722090003,63722100003, 63722120003,63722120004,63723010001,63723020 001,63723020002,63723050001,63723060001, 63723070001,63723070002,63723070003,63723080 002,63723080003,63723090002,63723090003, 63723090004,63723100003,63723100004,63723110 001,63723110003,63723120002