Brand Name: MEDLINE Product Name: SYR 30ML L/L Model/Catalog Number: 83078 Product Description: NON-Sterile syringes wit
Summary
The FDA issued a recall for Brand Name: MEDLINE Product Name: SYR 30ML L/L Model/Catalog Number: 83078 Produ by Jiangsu Shenli Medical Production Co., Ltd.. Reason: Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)..
Details
Source
Device Recall
External ID
f9d695e2-aac6-4f75-97d6-58908f099df7
Action Date
2024-05-29
Status
Ongoing
Category
device
Product Description
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
Lot/Code Info: 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
Quantity Affected: 4092250
Reason for Recall
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Distribution
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-04-05
Company
Context & Analysis
This is a unclassified recall.
This was one of 291 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Jiangsu Shenli Medical Production Co., Ltd. has 88 FDA actions in our database, including 88 recalls.
Frequently Asked Questions
What is a FDA recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Jiangsu Shenli Medical Production Co., Ltd.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Jiangsu Shenli Medical Production Co., Ltd. have FDA actions?
Jiangsu Shenli Medical Production Co., Ltd. has 88 FDA actions in our database, including 88 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "f9d695e2-aac6-4f75-97d6-58908f099df7" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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