Control Syringes and Related Devices FDA Regulatory Clearances Rescinded
Medline Industries has recalled Control Syringes (Model DNSC89369 and DYNJSYR10C), Guidewires, and High-Pressure Tubing after their FDA 510(k) regulatory clearances were rescinded. The devices were distributed nationwide.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves medical devices with rescinded FDA 510(k) clearances, which indicates loss of regulatory authorization for marketing. This is an FDA Class II recall affecting a large number of units (198,210) distributed nationwide, meeting the threshold for Severe severity.
Plain-English summary
Medline Industries, LP is recalling Control Syringes (Model DNSC89369: 8ML ROTATING and Model DYNJSYR10C: 10ML CONTROL), along with associated Guidewires and High-Pressure Tubing. The FDA has rescinded the 510(k) regulatory clearances for these devices, affecting 198,210 units distributed nationwide.
Affected lot numbers for the 8ML ROTATING model include DNSC89369 (Lot 25BDB731). The 10ML CONTROL model has 61 affected lot numbers ranging from 21ABS242 through 25GBK401. Consumers and healthcare facilities currently using or possessing these recalled devices should contact Medline Industries or the FDA for further instructions on proper handling and return procedures.
The recalled product
- Product
- Medline Kits: 1) SYR CONTROL 8ML ROTATING, Model Number: DNSC89369; 2) SYRINGE 10ML CONTROL MLL, Model Number: DYNJSYR10C
- Manufacturer
- Medline Industries, LP
- Hazard
- regulatory-clearance-rescission
- device-authorization-loss
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 1) DNSC89369
- UDI-DI: 10889942596225(each)
- 40889942596226(case)
- Lot Number: 25BDB731
- 2) DYNJSYR10C
- UDI-DI: 10884389676462(each)
- 40884389676463(case)
- Lot Number: 21BBM369
- 3) DYNJSYR10C
- Lot Number: 21DBO183
- 4) DYNJSYR10C
- Lot Number: 21DBY321
- 5) DYNJSYR10C
- Lot Number: 21FBC554
- 6) DYNJSYR10C
- Lot Number: 21FBJ020
- 7) DYNJSYR10C
- Lot Number: 21FBU555
- 8) DYNJSYR10C
- Lot Number: 21KBN994
Distribution
Distributed nationwide across the United States.