Device product
Medical Action Industries Inc. Pack Cath BHH, REF: BHCA49K, Sterile EO, Rx Only, QTY: 5/Case
Z-2007-2026
Product summary
- Event
- Event 98698
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 2030 kits
- Official record key
device-enforcement:Z-2007-2026
Official wording
Reason: Convenience kit contains a syringe in which the rotating adapter may unwind during use, resulting in a loose connection and/or full disconnection between the syringe and manifold"
Code information: UDI:20809160490294/ Lot numbers: 342509, 346066, 338434, 339423, 337365, 335489, 336189, 336789
Distribution pattern: US distribution to state of: AZ OUS: None
Derived failure modes
-
Unknown
Convenience kit contains a syringe in which the rotating adapter may unwind during use, resulting in a loose connection and/or full disconnection between the syringe and manifold"