Device recalls

Brand Name: MEDLINE Product Name: SYR 10ML L/L Model/Catalog Number: 83082 Product Description: NON-Sterile syringes without needles for si…

Jiangsu Shenli Medical Production Co., Ltd. · Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).

Open, ClassifiedNo Marketing ApplicationZ-2047-2024
Open FDA's page for this record
Cfres ID
207365
Product res number
Z-2047-2024
Event date initiated
2024-04-05
Event date posted
2024-05-20
Recall status
Open, Classified
Res event number
94520
Product code
FMF
Firm FEI number
3003902757
Recalling firm
Jiangsu Shenli Medical Production Co., Ltd.
Address 1
No. 20 Changzheng Road 20 Changzheng Road Zhengluzhen
Address 2
No.
City
Changzhou
Country
China
Additional info contact
Liqun Yang +8651988731071
Reason for recall
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Root cause description
No Marketing Application
Product quantity
38852100
Product description

Brand Name: MEDLINE Product Name: SYR 10ML L/L Model/Catalog Number: 83082 Product Description: NON-Sterile syringes without needles for single use Component: No

Code info

Lot Code: LOT: 63721010001,63721010003,63721010004,63721040002,63721050002,63721060001,63721060002, 63721070001,63721070002,63721070003,63721070004,63721070006,63721080001,63721080002, 63721080003,63721080004,63721080005,63721090002,63721090003,63721090004,63721100001, 63721100002,63721100003,63721100004,63721100005,63722030001,63722030002,63722030004, 63722040001,63722040003,63722040006,63722050001,63722050002,63722050005,63722060001, 63722060002,63722060003,63722070002,63722070003,63722070004,63722070006,63722080002, 63722080004,63722080005,63722080007,63722090002,63722090004,63722090005,63722090006, 63722120002,63723010002,63723020001,63723020003,63723030001,63723050001,63723050002, 63723050003,63723060001,63723060002,63723070001,63723070002,63723070003,63723080001, 63723080002,63723080003,63723090002,63723090003,63723090004,63723100003,63723100004, 63723100006,63723100008,63723110002,63723110003,63723110005,63723120002,63723120003, 63723120004,63723120005,63723120006

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 shenli@syringechina.com or telephone number 0086-519-88731071

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.

Harmonized identifiers (openFDA)
Device name
Syringe, Piston
Medical specialty description
General Hospital
Regulation number
880.5860
Device class
2
K number
K091377, K811167, K801311, K121124, K061275, K930321, K122023, K870192, K182279, K913235, K853450, K212207, K960882, K884921, K851089, K850958, K011176, K950666, K881980, K051720, K883744, K883094, K021993, K761158, K070264, K010890, K182274, K881791, K062365, K820294, K222744, K964597, K930791, K910520, K941020, K843473, K893862, K010708, K911440, K141762 +712 more
Registration number
3004111573, 3006948745, 3005853033, 9681413, 3012944064, 3024088964, 3023174629, 1647137, 8031007, 3006788678, 3014315664, 1410248, 3014747754, 3014615644, 3014680149, 1450662, 3027500452, 9612152, 9611024, 3008650117, 3005941719, 3004054016, 3012461127, 3007084575, 3011504993, 1066491, 3025432964, 3009746061, 3008808123, 3016245399, 3013517171, 3006498370, 3005405146, 3030412764, 3007007790, 3043226252, 3019807891, 3003152976, 3011230048, 1825034 +511 more
FEI number
1000268645, 3004111573, 3006948745, 3005853033, 3003056094, 3012944064, 3024088964, 3023174629, 1000306431, 3006788678, 3002808169, 3003857949, 3014315664, 1410248, 1000112877, 3014747754, 3014615644, 3014680149, 1450662, 3027500452, 3003640911, 3008650117, 3004054016, 3012461127, 3007084575, 3011504993, 3002808374, 3025432964, 3009746061, 3008808123, 3016245399, 3013517171, 3006498370, 3005405146, 3030412764, 3007007790, 3043226252, 3019807891, 3003152976, 3011230048 +511 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.