Recall Z-0351-2023 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
ARROW INTERNATIONAL Inc.
Arrow MAC Two-Lumen Central Venous Access Kit fr use with 7 - 7.5 Fr Catheters, REF ASK-11242-UPM1; catheter introducer
| Date | Dec 10, 2022 (initiated Oct 27, 2022) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process design |
| Action | The firm issued an "URGENT MEDICAL DEVICE RECALL" to its consignees on 10/27/2022 by FedEx 2-day mail. The notice explained the problem, the risk, and requested the following: "Action list number 1 Medical facilities 1. Immediately check your inventory for product within the scope of this recall. Users should cease use and distribution of affected product and immediately quarantine the affected product. 2. If you have affected product, complete the RECALL ACKNOWLEDGEMENT FORM, Contact Teleflex Customer Service to receive a return goods authorization (RGA) number. 3. Complete and return form |
| Quantity | 80 units |
| Distribution | US Distributor in states of: FL, GA, KY, OH, PA and WV. |
| FDA record | Open on fda.gov |