Z-0352-2023 Class I Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 21, 2022
- Initiation Date
- October 27, 2022
- Termination Date
- October 7, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1275 units
Product Description
Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit, REF numbers: a) ASK-42703-NS, b) ASK-42703-PCCH2, c) ASK-42703-PUPM1, d) ASK-45703-NS, e) ASK-45703-PAU, f) ASK-45703-PCAM1, g) ASK-45703-PCCH2, h) ASK-45703-PN; catheter introducer
Reason for Recall
There is the potential for inadequate connection between the top and bottom housings of the Micro Clave Clear Connectors included in the Arrow MAC Two-Lumen Central Venous Access Kit and the Arrow Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit.
Distribution Pattern
US Distributor in states of: FL, GA, KY, OH, PA and WV.
Code Information
a) ASK-42703-NS: UDI/DI 10801902162905, Lot Numbers: 13F22B0495 b) ASK-42703-PCCH2: UDI/DI 10801902141030, Lot Numbers: 13F22C0862 c) ASK-42703-PUPM1: UDI/DI 10801902159592, Lot Numbers: 13F22B0021 d) ASK-45703-NS: UDI/DI 10801902162912, Lot Numbers: 13F22C0244 e) ASK-45703-PAU: UDI/DI 10801902159110, Lot Numbers: 13F22D0121 f) ASK-45703-PCAM1: UDI/DI 10801902203158, Lot Numbers: 13F22C0553 g) ASK-45703-PCCH2: UDI/DI 10801902141047, Lot Numbers: 13F22B0641 h) ASK-45703-PN: UDI/DI 10801902140675, Lot Numbers: 13F22C0350