Recall Z-0723-2019 ยท DQY Catheter, Percutaneous
Arrow International Inc
Arrow CVC 2 Lumen, Pediatric Two-Lumen Central Venous Cauterization Set with Blue FlexTip Catheter, 4 Fr 2 Lumen 5cm, Reference # CS-12402 The Arrow CVC is intended to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access, including, but not limited to the following: " Lack of usable peripheral IV sites " Central venous pressu
| Date | Nov 14, 2018 |
| Status | Terminated |
| Reason | The lidstock states the incorrect priming volume and flow rates. |
| Root cause | Error in labeling |
| Action | The firm, Teleflex, sent an "Urgent Medical Device Notification" letter dated 11/13/2018 to its customers on 11/14/2018. The letter described the product, problem and action to be taken. The customers were instructed to do the following: 1. Place a copy of this notification with each unit of affected product currently in your inventory. 2. Using the provided customer letter template and acknowledgement form, communicate this notification to any of your customer who have received product included within the scope of this notification. 3. Have each of your customers who received the affected pr |
| Quantity | 15 in the US |
| Distribution | Worldwide distribution: US (nationwide) distribution to state of: FL and to countries of: Argentina, Canada, Chile, Columbia, Costa Rica, Dominican Republic, Ecuador, and Peru. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K862056 | [CENTRAL VENOUS][MULTI-LUMEN] CATHETER W/FLEX TIP Arrow Intl., Inc., Aug 25, 1986 |