510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
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Z-2127-2024Class II

Brand Name: MEDLINE Product Name: SYR 10ML/L BLUE CONTRAST Model/Catalog Number: 91848 Product Description...

Jiangsu Shenli Medical Production Co., Ltd. / initiated 2024-04-05 / Open, Classified
FDA source (opens on fda.gov)

Jiangsu Shenli Medical Production Co., Ltd. began a recall of Brand Name: MEDLINE Product Name: SYR 10ML/L BLUE CONTRAST Model/Catalog Number: 91848 Product Description: NON-Sterile syringes without needles for single use... on . FDA classified it as Class II and gives the reason as "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)". As of , the recall status on record is Open, Classified.

Recall record

Recall number
Z-2127-2024
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
Jiangsu Shenli Medical Production Co., Ltd.
Product
Brand Name: MEDLINE Product Name: SYR 10ML/L BLUE CONTRAST Model/Catalog Number: 91848 Product Description: NON-Sterile syringes without needles for single use Component: No
Product code
FMF Syringe, Piston
Reason for recall
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
FDA root cause
No Marketing Application
Action
On 05/14/2024, the firm emailed an "URGENT: MEDICAL DEVICE RECALL" Letter informing customers that Jiangsu Shenli Medical Production Co., Ltd. is recalling piston syringes that were distributed without premarket clearance. The Recalling Firm stated that they received an FDA Warning Letter that the piston syringes were not legally marketed devices. Customers are instructed to: Examine their inventory and stop/cease use of all syringe products subject to this action and report the inventory quantity to Jiangsu Shenli Medical Production Co., Ltd. Considering the complicated return process, and high cost of returning the products, the firm is instructing customers to dispose of these recalled syringes in the U.S, using their facility s approved/established procedures for disposal of medical products, or by contacting a local third party company to assist with the disposal of the recalled syringes. Please report the destruction method and cost with Shenli before final implementation. After product disposal, please provide Shenli with confirmation of destruction of products. For questions or assistance - contact the general manager at email [email protected] or telephone number 0086-519-88731071
Quantity in commerce
7000
Distribution
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.
Product codes and lots
Lot Code: LOT: 63721010001

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2127-2024
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2042-2024Class IIOngoingVoluntary: Firm initiated
Z-2043-2024Class IIOngoingVoluntary: Firm initiated
Z-2044-2024Class IIOngoingVoluntary: Firm initiated
Z-2045-2024Class IIOngoingVoluntary: Firm initiated
Z-2046-2024Class IIOngoingVoluntary: Firm initiated
Z-2047-2024Class IIOngoingVoluntary: Firm initiated
Z-2048-2024Class IIOngoingVoluntary: Firm initiated
Z-2049-2024Class IIOngoingVoluntary: Firm initiated
Z-2050-2024Class IIOngoingVoluntary: Firm initiated
Z-2051-2024Class IIOngoingVoluntary: Firm initiated
Z-2052-2024Class IIOngoingVoluntary: Firm initiated
Z-2053-2024Class IIOngoingVoluntary: Firm initiated
Z-2054-2024Class IIOngoingVoluntary: Firm initiated
Z-2055-2024Class IIOngoingVoluntary: Firm initiated
Z-2056-2024Class IIOngoingVoluntary: Firm initiated
Z-2057-2024Class IIOngoingVoluntary: Firm initiated
Z-2058-2024Class IIOngoingVoluntary: Firm initiated
Z-2059-2024Class IIOngoingVoluntary: Firm initiated
Z-2060-2024Class IIOngoingVoluntary: Firm initiated
Z-2061-2024Class IIOngoingVoluntary: Firm initiated
Z-2062-2024Class IIOngoingVoluntary: Firm initiated
Z-2063-2024Class IIOngoingVoluntary: Firm initiated
Z-2064-2024Class IIOngoingVoluntary: Firm initiated
Z-2065-2024Class IIOngoingVoluntary: Firm initiated
Z-2066-2024Class IIOngoingVoluntary: Firm initiated
Z-2067-2024Class IIOngoingVoluntary: Firm initiated
Z-2068-2024Class IIOngoingVoluntary: Firm initiated
Z-2069-2024Class IIOngoingVoluntary: Firm initiated
Z-2070-2024Class IIOngoingVoluntary: Firm initiated
Z-2071-2024Class IIOngoingVoluntary: Firm initiated
Z-2072-2024Class IIOngoingVoluntary: Firm initiated
Z-2073-2024Class IIOngoingVoluntary: Firm initiated
Z-2074-2024Class IIOngoingVoluntary: Firm initiated
Z-2075-2024Class IIOngoingVoluntary: Firm initiated
Z-2076-2024Class IIOngoingVoluntary: Firm initiated
Z-2077-2024Class IIOngoingVoluntary: Firm initiated
Z-2078-2024Class IIOngoingVoluntary: Firm initiated
Z-2079-2024Class IIOngoingVoluntary: Firm initiated
Z-2080-2024Class IIOngoingVoluntary: Firm initiated
Z-2081-2024Class IIOngoingVoluntary: Firm initiated
Z-2082-2024Class IIOngoingVoluntary: Firm initiated
Z-2083-2024Class IIOngoingVoluntary: Firm initiated
Z-2084-2024Class IIOngoingVoluntary: Firm initiated
Z-2085-2024Class IIOngoingVoluntary: Firm initiated
Z-2086-2024Class IIOngoingVoluntary: Firm initiated
Z-2087-2024Class IIOngoingVoluntary: Firm initiated
Z-2088-2024Class IIOngoingVoluntary: Firm initiated
Z-2089-2024Class IIOngoingVoluntary: Firm initiated
Z-2090-2024Class IIOngoingVoluntary: Firm initiated
Z-2091-2024Class IIOngoingVoluntary: Firm initiated
Z-2092-2024Class IIOngoingVoluntary: Firm initiated
Z-2093-2024Class IIOngoingVoluntary: Firm initiated
Z-2094-2024Class IIOngoingVoluntary: Firm initiated
Z-2095-2024Class IIOngoingVoluntary: Firm initiated
Z-2096-2024Class IIOngoingVoluntary: Firm initiated
Z-2097-2024Class IIOngoingVoluntary: Firm initiated
Z-2098-2024Class IIOngoingVoluntary: Firm initiated
Z-2099-2024Class IIOngoingVoluntary: Firm initiated
Z-2100-2024Class IIOngoingVoluntary: Firm initiated
Z-2101-2024Class IIOngoingVoluntary: Firm initiated
Z-2102-2024Class IIOngoingVoluntary: Firm initiated
Z-2103-2024Class IIOngoingVoluntary: Firm initiated
Z-2104-2024Class IIOngoingVoluntary: Firm initiated
Z-2105-2024Class IIOngoingVoluntary: Firm initiated
Z-2106-2024Class IIOngoingVoluntary: Firm initiated
Z-2107-2024Class IIOngoingVoluntary: Firm initiated
Z-2108-2024Class IIOngoingVoluntary: Firm initiated
Z-2109-2024Class IIOngoingVoluntary: Firm initiated
Z-2110-2024Class IIOngoingVoluntary: Firm initiated
Z-2111-2024Class IIOngoingVoluntary: Firm initiated
Z-2112-2024Class IIOngoingVoluntary: Firm initiated
Z-2113-2024Class IIOngoingVoluntary: Firm initiated
Z-2114-2024Class IIOngoingVoluntary: Firm initiated
Z-2115-2024Class IIOngoingVoluntary: Firm initiated
Z-2116-2024Class IIOngoingVoluntary: Firm initiated
Z-2117-2024Class IIOngoingVoluntary: Firm initiated
Z-2118-2024Class IIOngoingVoluntary: Firm initiated
Z-2119-2024Class IIOngoingVoluntary: Firm initiated
Z-2120-2024Class IIOngoingVoluntary: Firm initiated
Z-2121-2024Class IIOngoingVoluntary: Firm initiated
Z-2122-2024Class IIOngoingVoluntary: Firm initiated
Z-2123-2024Class IIOngoingVoluntary: Firm initiated
Z-2124-2024Class IIOngoingVoluntary: Firm initiated
Z-2125-2024Class IIOngoingVoluntary: Firm initiated
Z-2126-2024Class IIOngoingVoluntary: Firm initiated
Z-2127-2024Class IIOngoingVoluntary: Firm initiated
Z-2128-2024Class IIOngoingVoluntary: Firm initiated