Brand Name: MEDLINE Product Name: SYR 3ML L/S Model/Catalog Number: 83083 Product Description: NON-Sterile syringes without needles for sin…
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 FDA's page for this record- Cfres ID
- 207366
- Product res number
- Z-2048-2024
- Event date initiated
- 2024-04-05
- Event date posted
- 2024-05-20
- Recall status
- Open, Classified
- Res event number
- 94520
- Product code
- FMF
- Product description
- Brand Name: MEDLINE Product Name: SYR 3ML L/S Model/Catalog Number: 83083 Product Description: NON-Sterile syringes without needles for single use Component: No
- 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
- 494000
- Code info
Lot Code: LOT: 63721010004,63721020002,63721040002,63721050002,63721060001,63721070001,63721080001, 63721090001,63721110001,63721120001,63722010001,63722020003,63722030001,63722050006, 63722060001,63722070005,63722080002,63722090002,63722100003,63722120002,63723020001, 63723030001,63723060001,63723070001,63723090002,63723100003,63723120002
- 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