Recall Z-0053-2020 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Arrow International Inc
Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter, REF AK-25502 Product Usage; Provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access
| Date | May 17, 2019 |
| Status | Terminated |
| Reason | Lidstock contains a labeling error. The lidstock shows the catheter cross section of the gauge (GA) values in a reversed manner. |
| Root cause | Employee error |
| Action | On May 17, 2019, Arrow International issued Urgent Medical Device and Acknowledgement notices to customers via courier service. Customers should take the following actions: 1. Place a copy of the notification with each unit of affected product currently in your inventory. 2. After step (1) is complete, fill out the enclosed Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email it to recalls@teleflex.com. Distributors should take the following actions: 1. Place a copy of the notification with each unit of affected product currently in your inventory. 2. Using t |
| Quantity | 3,143 |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K900263 | ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETER Arrow Intl., Inc., Jul 24, 1990 |